Vol. 78 Wednesday, 

No. 233 December 4, 2013 

Part II 

Department of Agriculture 

Animal and Plant Health Inspection Service 

9 CFR Parts 92, 93, 94, et al. 

Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine 

Products; Final Rule 

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72980 Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Rules and Regulations 

1To view the proposed rule, supporting 

documents, and the comments we received, go to 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 92, 93, 94, 95, 96, and 98 

[Docket No. APHIS–2008–0010] 

RIN 0579–AC68 

Bovine Spongiform Encephalopathy; 

Importation of Bovines and Bovine 

Products 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are amending the 

regulations that govern the importation 

of animals and animal products to 

revise the conditions for the importation 

of live bovines and products derived 

from bovines with regard to bovine 

spongiform encephalopathy (BSE). We 

are basing importation conditions on the 

inherent risk of BSE infectivity in 

specified commodities, as well as on the 

BSE risk status of the region in which 

the commodities originate. We are 

establishing a system for classifying 

regions as to BSE risk that is consistent 

with the system employed by the World 

Organization for Animal Health (OIE), 

the international standard-setting 

organization for guidelines related to 

animal health. The conditions we are 

adopting for the importation of specified 

commodities are based on 

internationally accepted scientific 

literature, and are, in general, consistent 

with guidelines set out in the OIE’s 

Terrestrial Animal Health Code. We are 

also classifying certain specified 

countries as to BSE risk and are 

removing BSE restrictions on the 

importation of cervids and camelids and 

products derived from such animals. We 

are making these amendments after 

conducting a thorough review of 

relevant scientific literature and a 

comprehensive evaluation of the issues 

and concluding that the changes to the 

regulations will continue to guard 

against the introduction of BSE into the 

United States, while allowing the 

importation of additional animals and 

animal products into this country. 

DATES: This rule is effective March 4, 

2014. The incorporation by reference of 

the material described in the rule is 

approved by the Director of the Federal 

Register as of March 4, 2014. 

FOR FURTHER INFORMATION CONTACT: For 

information concerning live ruminants, 

contact Dr. Betzaida Lopez, Import 

Animal Staff Veterinarian, Technical 

Trade Services, Animals, Organisms and 

Vectors, and Select Agents, National 

Center for Import and Export, VS, 

APHIS, 4700 River Road, Unit 39, 

Riverdale, MD 20737–1231; 301–851– 

3300. 

For information regarding ruminant 

products and for other information 

regarding this rule, contact Dr. 

Christopher Robinson, Assistant 

Director, Technical Trade Services, 

Animal Products, National Center for 

Import and Export, VS, APHIS, 4700 

River Road, Unit 38, Riverdale, MD 

20737–1231; 301–851–3300. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

Need for the Regulatory Action 

The conditions we are adopting for 

the importation of specified bovine 

commodities are based on 

internationally accepted scientific 

literature and are, in general, consistent 

with World Organization for Animal 

Health (OIE) guidelines. We are making 

these amendments after conducting a 

thorough review of relevant scientific 

literature and a comprehensive 

evaluation of the issues and concluding 

that the changes we are making to the 

regulations will continue to guard 

against the introduction of bovine 

spongiform encephalopathy (BSE) into 

the United States, while allowing the 

importation of additional animals and 

animal products into this country. 

The OIE recognizes three 

classifications of countries for BSE: 

Negligible risk, controlled risk, and 

undetermined risk. The OIE guidelines 

recommend that countries allow trade 

in certain bovine commodities from all 

three classifications under conditions 

commensurate with their BSE risk. This 

final rule generally aligns U.S. 

regulations with the OIE guidelines and 

demonstrates to the international 

community the commitment of the 

United States to base its BSE regulations 

on internationally accepted scientific 

literature. 

Legal Authority for the Regulatory 

Action 

Under the Animal Health Protection 

Act (AHPA, 7 U.S.C. 8301 et seq.), the 

Secretary of Agriculture has the 

authority to issue orders and promulgate 

regulations to prevent the introduction 

into the United States and the 

dissemination within the United States 

of any pest or disease of livestock. The 

Animal and Plant Health Inspection 

Service’s (APHIS’) regulations in title 9 

of the Code of Federal Regulations, 

subchapter D, govern the exportation 

and importation of animals (including 

poultry) and animal products from and 

into the United States. 

Summary of the Major Provisions of the 

Regulatory Action 

The current regulations prohibit the 

importation of live ruminants and most 

ruminant products from regions that 

have BSE or that present an undue risk 

for BSE. The regulations are less 

restrictive for ruminants and ruminant 

products from BSE minimal-risk regions 

(currently only Canada). Additionally, 

the regulations allow the importation of 

boneless beef from Japan even though 

Japan is listed as a region that has BSE. 

We are replacing the current BSE 

regulations that apply to bovines (cattle 

and bison) with import conditions based 

on the inherent risk of BSE infectivity 

in specified commodities, as well as on 

the BSE risk status of the region in 

which the commodities originate. We 

are establishing a system for classifying 

regions as to BSE risk that is consistent 

with the system employed by the OIE, 

the international standard-setting 

organization for guidelines related to 

animal health. We are also classifying 

certain specified countries as to BSE 

risk. We are also removing BSE 

restrictions on the importation of 

cervids and camelids and products 

derived from such animals. 

Costs and Benefits 

Consumers benefit from imports to 

the extent that consumer choice is 

broadened and the increased supply of 

the imported commodity leads to a price 

decline. We anticipate that the rule will 

have little impact on consumer choice 

or import volumes, and therefore little 

or no impact on U.S. businesses as well. 

Although the impact of this rule on U.S. 

consumers and producers is expected to 

be minimal, the benefits of the rule are 

expected to justify its costs. 

II. Background 

In order to guard against the 

introduction and spread of animal 

diseases, APHIS, an agency of the U.S. 

Department of Agriculture (USDA or 

Department), regulates the importation 

of animals and animal products into the 

United States. The regulations in 9 CFR 

parts 92, 93, 94, 95, 96, and 98 (referred 

to below as the regulations) govern the 

importation of certain animals, meat, 

other animal products and byproducts, 

hay, and straw into the United States in 

order to prevent the introduction of 

various animal diseases. 

On March 16, 2012, we published in 

the Federal Register (77 FR 15848– 

15913, Docket No. APHIS–2008–0010) a 

proposal 1 to amend the regulations that 

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Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Rules and Regulations 72981 

http://www.regulations.gov/

#!docketDetail;D=APHIS-2008-0010. 

govern the importation of animals and 

animal products to revise the conditions 

for the importation of live bovines and 

products derived from bovines with 

regard to BSE. Specifically, we proposed 

to base our importation conditions on 

the inherent risk of BSE infectivity in 

specified commodities, as well as the 

BSE risk status of the region in which 

the commodities originate, consistent 

with the OIE’s Terrestrial Animal Health 

Code. We proposed to establish a system 

for classifying regions as to BSE risk that 

is consistent with the system employed 

by the OIE. The conditions we proposed 

for the importation of specified 

commodities are based on 

internationally accepted scientific 

literature and, are, in general, consistent 

with the guidelines set out in the OIE’s 

Terrestrial Animal Health Code. We also 

proposed to classify certain specified 

countries as to BSE risk and proposed 

to remove BSE restrictions on the 

importation of cervids and camelids and 

products derived from such animals. 

In the same document we also 

affirmed the position we took in 

removing the delay of applicability of 

certain provisions of the rule titled 

‘‘Bovine Spongiform Encephalopathy; 

Minimal-Risk Regions and Importation 

of Commodities,’’ published in the 

Federal Register on January 4, 2005 (70 

FR 460–553, Docket No. 03–080–3). The 

delay of applicability was removed in a 

final rule titled ‘‘Bovine Spongiform 

Encephalopathy; Minimal Risk Regions; 

Importation of Live Bovines and 

Products Derived from Bovines,’’ 

published in the Federal Register on 

September 18, 2007 (72 FR 53314– 

53379, Docket No. APHIS–2006–0041). 

However, as ordered by the U.S. District 

Court on July 3, 2008, APHIS provided 

additional opportunity for public 

comment on this action in a notice 

published in the Federal Register on 

September 18, 2008 (73 FR 54083– 

54089, Docket No. APHIS–2008–0093). 

We responded to comments received on 

that notice in our March 2012 proposed 

rule. 

We solicited comments concerning 

our proposal for 60 days ending May 15, 

2012. We reopened and extended the 

deadline for comments until June 14, 

2012, in a document published in the 

Federal Register on May 21, 2012 (77 

FR 29914, Docket No. APHIS–2008– 

0010). We received 60 comments by that 

date. They were from private citizens, 

domestic and foreign industry 

associations, importers, exporters, and 

representatives of State and foreign 

governments. The commenters raised a 

number of questions and concerns about 

the proposed rule. These comments and 

concerns are discussed below by topic. 

General Concerns 

One commenter stated that APHIS did 

not give appropriate consideration to, 

and in some cases did not address at all, 

some of the concerns raised by the 

public on the notice requesting 

comment on the delay of applicability of 

certain provisions of the rule titled 

‘‘BSE; Minimal-Risk Regions and 

Importation of Meat, Meat Byproducts, 

and Meat Food Products Derived from 

Bovines 30 Months of Age or Older’’ 

(the OTM [i.e., over 30 months] rule) (73 

FR 54083–54089, Docket No. APHIS– 

2008–0093). 

APHIS disagrees. In the proposed 

rule, we responded to comments on our 

removal of the delay of applicability of 

provisions of our January 2005 final 

rule. We are confident that we 

responded to all the comments. 

The commenter stated that in the 

September 2008 request for comments, 

APHIS mischaracterized its document 

published in the Federal Register on 

March 8, 2004 (69 FR 10633–10636, 

Docket No. 03–080–2), as proposing to 

allow the importation from BSE 

minimal-risk regions of beef derived 

from cattle of any age. The March 2004 

document reopened a comment period 

for a proposed rule published on 

November 4, 2003 (68 FR 62386–62405, 

Docket No. 03–080–1) and invited 

public comment on changing that 

proposed rule to allow the importation 

of beef from bovines 30 months of age 

and older based on new requirements 

issued by USDA’s Food Safety and 

Inspection Service (FSIS). The 

commenter stated that the March 2004 

document contained no reference to the 

importation of beef from cattle of any 

age and instead continued to propose a 

restriction on the age of cattle by 

retaining the requirement contained in 

the November 2003 proposed rule that 

the beef be derived from animals that 

are not known to have been fed 

ruminant protein, other than milk 

protein, during their lifetime. 

When we stated in our September 

2008 request for comments that our 

March 2004 document proposed to 

allow the importation of beef derived 

from cattle of any age, we meant that the 

derivation of beef from bovines 30 

months of age or older when 

slaughtered would not in itself preclude 

the commodities from being imported. 

We stated further that we were not 

referring to any effect the feed ban 

requirement might have on the import 

eligibility of the commodities. 

The terminology regarding ‘‘cattle of 

any age’’ that we used in our September 

2008 request for comments was 

consistent with that which we used in 

the risk analysis for our January 2005 

final rule. The commenter stated that 

this terminology was not consistent 

with the risk assessment which 

supported the January 2005 final rule. 

We note that the risk analysis that 

accompanied the January 2005 final rule 

stated: ‘‘It is important to note the 

following change in the final rule. In its 

proposed rule, APHIS restricted beef 

imported from Canada to meat derived 

from cattle under 30 months of age. This 

requirement has been removed in the 

final rule, and beef from animals of any 

age will be allowed to be imported from 

a Minimal Risk region.’’ In the January 

2005 final rule, we explained that we 

did not believe this requirement was 

necessary, provided that measures 

equivalent to those of FSIS regarding 

specified risk material (SRM) removal 

are in place in the exporting region and 

other such measures as are necessary 

(e.g., a prohibition on the use of air 

injection stunning devices and controls 

to prevent cross-contamination) are in 

place. We believe that this clearly lays 

out the intent that APHIS did not apply 

any specific age limitation to the import 

of beef. 

One commenter stated that, despite 

the fact that APHIS stated in the 

proposed rule that it is not necessary to 

revise any provisions in the OTM rule, 

the proposed rule makes substantive 

revisions to the OTM rule, including 

revisions to the provisions that APHIS 

stated were essential to its affirmation of 

the OTM rule. 

The commenter is correct in noting 

that this rule revises the existing 

regulations, including the existing 

regulations that addressed the 

importation of animals and products 

from BSE minimal risk regions. As 

described in the proposed rule, APHIS 

noted that the existing regulations 

contain provisions that are not yet fully 

consistent with the latest scientific 

literature. APHIS regulations have 

changed over time, as we gain increased 

understanding of the science of BSE and 

conduct further risk assessments. The 

changes we proposed reflected 

internationally accepted scientific 

literature and, in general, are consistent 

with the OIE Code. 

We assume that the commenter is 

referring to the specific issue of whether 

or not certification about a feed ban is 

necessary in the conditions for beef 

imports. APHIS initially imposed such 

a certification requirement, noted in 

both the 2003 proposed rule and the 

January 2005 final rule. This 

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requirement was not amended in our 

2007 final rule when we lifted the delay 

of applicability on certain imports from 

Canada. In contrast, our regulations for 

the importation of boneless beef from 

Japan do not include any certification 

about the feeding practices for the 

animals from which the beef was 

derived. In both instances, however, we 

considered the significant overall risk 

reduction achieved in each country by 

their respective feed bans. Such feed 

bans decrease the overall prevalence of 

BSE and therefore reduce the risk that 

any individual animal may be exposed 

to potentially infected feed. They 

continue to be a crucial risk mitigation 

measure that is considered in any 

overall risk assessment for BSE. 

However, since they are crucial to the 

consideration of the overall status of the 

country, requiring specific certification 

to that effect for individual animals 

from which meat for export is derived 

is redundant. The feed ban requirement 

is covered in that consideration of the 

country’s BSE risk. Therefore, in line 

with OIE recommendations, we did not 

include that specific certification 

statement in the proposed requirements 

for beef imports from controlled risk 

regions. Such certification is, however, 

required for beef imports from 

undetermined risk regions. For these 

regions, either no information is 

available about any feed ban 

requirements or other risk mitigation 

measures, or they have not maintained 

the relevant risk mitigation measures 

sufficient to meet the standards for 

controlled or negligible risk. Therefore, 

we cannot rely on the overall country 

evaluation to ensure that a feed ban is 

in place and will require certification 

that the animals from which the meat 

was derived were never fed meat-andbone meal or greaves derived from 

ruminants. These requirements are 

consistent with our risk assessments 

that demonstrate that an effective feed 

ban is a critical risk mitigation measure 

that must be in place in regions that 

have a potential risk of BSE. 

One commenter stated that the OIE 

Code is not universally recognized as 

the international standard for BSE 

prevention, mitigation, and 

surveillance. The commenter noted that 

some countries, such as Japan and 

Australia, have established their own 

standards, which are stricter than those 

of the OIE. The commenter stated that 

APHIS should provide better 

justification for adopting OIE standards. 

As we explained in the proposed rule, 

the World Trade Organization 

recognizes the OIE as the international 

forum for setting animal health 

standards, reporting global animal 

disease events, and presenting 

guidelines and recommendations on 

sanitary measures relating to animal 

health. As an OIE Member country, the 

United States reviews and, where 

appropriate, comments on all draft OIE 

chapters and revisions. As part of the 

United States’ consideration of OIE 

drafts, APHIS distributes these drafts to 

the U.S. livestock and aquaculture 

industries, veterinary experts in various 

U.S. academic institutions, and other 

interested persons for review and 

comment. Furthermore, the United 

States, represented by APHIS, has been 

actively involved in the development of 

the OIE Code and fully supports the OIE 

position that gradations in BSE risk 

among regions should be recognized 

and that trade should be commensurate 

with risk. 

One commenter stated that 

surveillance for BSE in the United 

States is inadequate. The commenter 

stated that U.S. surveillance has 

decreased 90 percent since 2005, and 

that the United States only tests cattle 

showing symptoms of BSE. The 

commenter stated that all cattle should 

be tested for BSE at slaughter and that 

such testing would not be prohibitively 

expensive. 

APHIS disagrees with the commenter. 

BSE surveillance programs in the 

United States focus on obtaining quality 

samples from targeted subpopulations 

rather than looking at the entire adult 

cattle population. Targeted animals are 

cattle older than 30 months of age that 

exhibit signs of central nervous 

disorders or any other signs associated 

with BSE, such as emaciation or injury. 

Dead cattle and non-ambulatory cattle 

are also targeted. The experience in the 

United Kingdom (UK) has shown that 

those populations are most likely to test 

positive for BSE in the event that the 

animals were exposed to the agent and 

lived long enough to develop the 

disease. We note that surveillance is not 

a BSE mitigation; that is, it does not 

provide a level of protection against the 

disease. It only allows us to understand 

disease trends such as prevalence and 

evolution of the disease, and to evaluate 

the effectiveness of risk mitigation 

measures. The removal of SRMs and the 

ruminant-to-ruminant feed ban are the 

primary safeguards to human and 

animal health. 

One commenter stated that the 

proposed testing rates are too low. The 

commenter asked how a region can be 

considered negligible risk if only a small 

percentage of cattle are tested for BSE. 

Surveillance is only one part of the 

evaluation. A region applying for 

negligible risk status must show 

compliance with BSE-related 

mitigations for a period of at least 7 or 

8 years. In addition, the region must 

show that the likelihood of release and 

exposure to the BSE agent is negligible. 

As we explained above, BSE 

surveillance provides information 

regarding prevalence, changes in the 

epidemiology of the disease, and 

effectiveness of the BSE risk mitigation 

measures. 

One commenter stated that the United 

States typically imports more than 2 

million head of cattle each year. The 

commenter asked how APHIS supported 

the statement that imported cattle 

represent only a small portion of cattle 

in U.S. feedlots. 

According to data from the National 

Agricultural Statistics Service (NASS), 

of the approximately 2.2 million bovine 

animals imported annually for the years 

2009–2011, about 1.3 million were 

feeder cattle. NASS data also show that 

an average of 25.8 million cattle was 

marketed annually by feedlots in the 

years 2009–2011. Based on this 

information, APHIS estimates that 

approximately 5 percent of cattle in U.S. 

feedlots were imported. 

One commenter stated that APHIS did 

not address the lack of reported BSE 

cases in regions where cattle are 

primarily grass-fed, nor did APHIS 

evaluate the import and export 

standards of these countries. 

Under Chapter 11.5.2 of the OIE Code, 

a release assessment must be conducted 

as the first step in determining the BSE 

risk status of a region. The release 

assessment considers the likelihood that 

the BSE agent has either been 

introduced into the region via 

commodities potentially contaminated 

with it, or is already present in the 

region. The elements considered 

include production of meat-and-bone 

meal or greaves from the indigenous 

ruminant population, imported meatand-bone meal or greaves, and imported 

animal feed and feed ingredients in a 

region. Furthermore, if the release 

assessment identifies a risk factor, an 

exposure assessment is conducted, 

which considers the likelihood of cattle 

being exposed to the BSE agent by 

reviewing such elements as recycling 

and amplification of the BSE agent 

through consumption by cattle of meatand-bone meal or greaves of ruminant 

origin, or other feed or feed ingredients 

contaminated with these; the use of 

ruminant carcasses (including from 

fallen stock), by-products, and 

slaughterhouse waste; the parameters of 

the rendering processes and the 

methods of animal feed manufacture; 

and the feeding or not of ruminants with 

meat-and-bone meal and greaves 

derived from ruminants, including 

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measures to prevent crosscontamination of animal feed. APHIS 

notes that those countries where cattle 

are primarily raised on grass, such as 

Argentina and Brazil, are considered 

negligible risk in part because livestock 

practices in those regions contribute a 

very low likelihood of exposure to 

ruminant materials through bovine feed. 

One commenter stated that the 

proposed rule is full of exceptions that 

would allow importation of live cattle 

and bovine products from all three risk 

categories, which presents an 

unacceptable amount of risk to 

consumers. 

The commenter is incorrect that 

under the provisions of the proposed 

rule, live cattle could be imported from 

regions of all three risk categories. Only 

cattle born after the date of effective 

enforcement of a ruminant-to-ruminant 

feed ban would be allowed entry from 

controlled risk regions, and live cattle 

from regions of undetermined risk 

would be allowed only on a case-bycase basis when the Administrator 

determines that they do not present a 

risk of introducing BSE into the United 

States. While the rule provides for the 

importation of deboned skeletal meat 

from all regions, that provision, as well 

as the provisions for the importation of 

other products, is closely aligned with 

international standards, particularly as 

they require SRM removal and steps to 

prevent the contamination of the 

products with SRMs. 

Four commenters noted that the 

phrase ‘‘full-time salaried veterinary 

officer of the national government of the 

exporting region’’ is used throughout 

the rule. One commenter stated that the 

phrase was not in alignment with the 

provisions in Chapter 5.2.2 of the OIE 

Code. The commenter asked if a 

veterinarian employed part-time as a 

government veterinary officer would be 

excluded from signing the required 

certificates. Another commenter asked 

that we consider eliminating the 

requirement, noting that in the joint 

initial action plan for the Regulatory 

Cooperation Council announced by 

Canadian Prime Minister Harper and 

President Obama on December 7, 2011, 

the current requirement for a veterinary 

signature for meat export certificates 

was cited as an example of a 

requirement which creates a burden for 

regulators as well as for industry. A 

third commenter stated that APHIS 

should build in suitable flexibility to 

allow certificates to be signed by 

inspectors who are under the 

supervision of the official veterinarian. 

This commenter also suggested that 

APHIS ensure there is sufficient 

flexibility to allow for the use of various 

forms of certification, such as paper and 

electronic certification. 

In the proposed rule, we provided for 

certificates to be signed either by a fulltime salaried veterinary officer of the 

national government of the exporting 

region or issued by a veterinarian 

designated or accredited by the national 

government of the exporting region and 

endorsed by a full-time salaried 

veterinary officer. When evaluating a 

country we consider whether or not it 

has the infrastructure and veterinary 

authority to comply with the APHIS 

certification requirements. If, as a result 

of our evaluation, we conclude that the 

country has the necessary infrastructure, 

and if the competent veterinary 

authority can attest to APHIS that the 

competent official has oversight over 

certifying a process or product, then 

APHIS can accept that signature. We 

have amended the requirements in 

§§ 94.18, 94.19, 94.20, and 94.21 to 

require that certificates must be issued 

and signed by a full-time salaried 

veterinary officer of the national 

government of the exporting region or 

signed by a person authorized to issue 

such certificates by the veterinary 

services of the national government of 

the exporting region. APHIS recognizes 

the need to move to electronic 

certification in the trade environment, 

and is working to find ways to 

implement it in the future. 

Regions of Negligible Risk, Controlled 

Risk, and Undetermined Risk for BSE 

One commenter stated that OIE’s risk 

categorizations of regions are based on 

self-reported data, and that a scientific 

committee assesses applications for 

compliance with OIE standards only 

after a recommendation for a risk 

designation is made. The commenter 

stated that this process is inherently 

unreliable and not subject to rigorous 

verification. 

The OIE recommendation for a 

region’s BSE risk categorization is based 

on the decision reached by the 

Scientific Commission after receiving a 

recommendation from the OIE BSE ad 

hoc group. The members of both groups 

are aware of BSE trends and geographic 

impacts related to trade among regions. 

Consequently, the scientific 

commission’s decision is based not only 

on the country’s self-reported data, but 

also on the potential impact on the 

country’s BSE status of its trading 

partners’ BSE status, the country’s 

historical trade in specific commodities, 

and the impact of BSE-related risk 

mitigation in the region. 

One commenter asked what the 

justification was for considering a 

region to be ‘‘negligible risk’’ if it has at 

least one indigenous case of BSE, but 

the BSE-positive animal was born more 

than 11 years ago, is officially 

identified, is controlled in its 

movements, and completely destroyed 

at slaughter or death. The commenter 

also asked for an explanation of the 11- 

year limitation. 

To achieve negligible risk status, the 

country must comply with stringent 

criteria, including the requirement that 

the youngest case reported by the 

country has to be older than 11 years. 

This requirement relates to the 

likelihood that contaminated feed that 

the BSE case was potentially exposed to 

11 years ago (during its first year of life) 

will no longer be circulating. This is in 

line with classical BSE data showing 

that cattle developed disease between 

4.5 and 6 years of age following the 

1990–early 2000 European BSE 

experience. By year 11 after exposure, 

over 95 percent of the BSE cases in 

Europe experienced disease. Therefore 

we expect most cases would be detected 

within 11 years. 

One commenter stated that the 

definitions of ‘‘negligible risk’’ and 

‘‘controlled risk’’ status in the proposed 

rule are substantively the same as those 

of the OIE, and are therefore superfluous 

in the proposed rule. The commenter 

stated that OIE classification and 

interpretation should be sufficient. 

The OIE Code consists of guidelines 

for international trade in live animals 

and their parts and products. While 

these guidelines are recognized as 

international standards, they do not 

have the force or effect of law within the 

United States. For this reason we need 

to establish these definitions in our 

regulations. 

One commenter stated that in the 

proposed rule, we proposed to establish 

a notice-based approach for recognizing 

OIE risk categorization for countries, but 

then we also solicited comment on 

certain countries before the process was 

established. The commenter opposed 

recognizing the OIE risk categorization 

for the countries listed before the noticebased approach was established in the 

regulations. 

In the proposed rule, we announced 

that we were giving preliminary 

concurrence to the OIE risk 

classifications of several countries and 

gave the public opportunity to 

comment, just as we would have done 

in a rulemaking. We received no 

comments that opposed this 

concurrence for any of the countries we 

discussed in the proposed rule. 

Several commenters noted that the 

OIE recognizes Singapore and India as 

countries of negligible risk for BSE, and 

Taiwan as a region of controlled risk, 

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72984 Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Rules and Regulations 

but that those countries were not 

included on the list of regions for which 

APHIS concurred with the OIE 

classification. 

Singapore was omitted from the list 

by mistake. In the cases of India and 

Taiwan, we were not able to complete 

our review of information in support of 

concurrence with the OIE designation 

before the publication of the proposed 

rule. We have since concluded our 

review of information for Taiwan and 

are announcing preliminary 

concurrence with the OIE designations 

for Singapore and Taiwan in a notice 

published today in the Federal Register 

in accordance with the process we are 

adopting in this final rule. The OIE 

recommendations regarding Singapore 

and Taiwan can be viewed at http://

www.oie.int/en/animal-health-in-theworld/official-disease-status/bse/list-ofbse-risk-status/. This notice will also 

announce preliminary concurrence with 

the most recent OIE designations for 

Austria, Belgium, Bulgaria, Brazil, 

Colombia, Costa Rica, Croatia, Israel, 

Italy, Japan, the Netherlands, Nicaragua, 

and Slovenia. 

Our review of information in support 

of concurrence with the OIE designation 

for India is ongoing. When our review 

is complete, if the findings support 

concurrence with the OIE designation, 

we will publish a notice in the Federal 

Register announcing our preliminary 

concurrence with the OIE’s designation 

for India and provide the public with an 

opportunity to comment. 

One commenter asked if we intended 

to announce in the final rule the 

concurrence decision for countries that 

have already received OIE classification. 

Yes. Those regions for which we 

announced preliminary concurrence 

will be recognized accordingly. 

Two commenters stated that the 

United States should accept OIE risk 

classification without conducting 

duplicative reviews. One of these stated 

that the United States, as a member of 

the OIE, should give automatic 

recognition to the OIE risk 

classification. 

APHIS will not be conducting 

duplicative reviews, but will verify that 

the information is provided or is 

publicly available to support our 

concurrence with the OIE classification. 

APHIS’ intention is to follow the OIE’s 

BSE guidelines while ensuring that OIErecognized countries apply adequate 

BSE risk mitigation measures assuring 

that bovines and bovine commodities 

destined for export pose a negligible risk 

for BSE, and that the country complies 

with OIE requirements for the specific 

BSE country recognition. APHIS will 

thus have greater confidence in the 

outcomes of the evaluations and will 

have the necessary documentation to 

support or defend recognition decisions. 

The process we will use is described in 

the regulatory text in this document for 

§ 92.5. 

One commenter asked if APHIS 

would proactively update its lists of 

regions of negligible and controlled risk 

according to future changes in the OIE 

lists, or if APHIS would act only after 

receiving an official request from the 

country. 

APHIS will automatically look to 

concur with future OIE recognitions of 

a region’s BSE status. 

One commenter asked if APHIS 

intends to actually reassess each dossier 

before proposing to concur with OIE 

classification. 

It is not APHIS’ intention to do a 

separate evaluation apart from the OIE’s 

evaluation. Rather, APHIS will confirm 

that there is information available to 

support our concurrence with the OIE 

classification. 

One commenter asked if APHIS will 

accept dossiers written in languages 

other than English. 

No, APHIS will not accept dossiers in 

languages other than English. 

Two commenters expressed concern 

that APHIS plans to determine the BSE 

risk designation of any country or region 

via a rulemaking process. One 

commenter stated that the length of the 

rulemaking process is unpredictable and 

that use of a rulemaking process would 

introduce uncertainty. The other 

commenter suggested that APHIS 

maintain a list on a Web site and 

harmonize notification with that of the 

OIE. 

Since this final rule establishes our 

system for classifying regions as to BSE 

risk be consistent with the OIE’s BSE 

risk categorization of regions, APHIS 

does not plan to use a rulemaking 

process to announce concurrence with 

OIE recognition of BSE status. Instead, 

when we concur with the OIE decision 

on the BSE status of a region, we will 

publish a notice in the Federal Register 

announcing our intention to concur and 

to solicit public comment. If we do not 

receive comments that require us to 

reconsider our decision to concur, we 

will publish a subsequent notice to 

announce our concurrence with the OIE 

classification and we will update our 

Web site. Announcing our concurrence 

through this notice process, which 

includes obtaining and evaluating 

public comments, among other 

information, before making a final 

decision on our concurrence, is an 

appropriate process to use. 

One commenter asked if countries 

that have received an OIE risk 

designation will be required to submit 

any particular information to APHIS in 

order to receive concurrence. 

In order to determine whether we 

concur with OIE’s classification, APHIS 

will review publicly available 

information. If sufficient information is 

not publicly available, we will ask 

countries to provide us with the 

documentation submitted to the OIE 

when that country requested official 

recognition of its BSE risk status. We 

will then review the documentation 

provided and make our evaluation 

available to the public for comment. 

Four commenters noted that we 

would require regions evaluated by 

APHIS for BSE risk to submit updated 

information every year. Some of these 

commenters asked whether APHIS will 

rely on OIE’s annual review for 

countries originally classified by OIE, or 

whether we would expect these 

countries to provide updated 

information to APHIS on a yearly basis. 

One commenter expressed concern that 

if APHIS requires this information from 

trading partners classified by OIE, it 

may set a precedent for other trading 

partners to ask for the same information, 

which would undermine OIE’s 

categorization process. 

We proposed to allow for APHIS 

recognition of a region as a region of 

negligible risk or controlled risk in one 

of two ways. The first way would be for 

APHIS to concur with the OIE 

classification of the region of either 

negligible or controlled risk. The second 

way would be for a region that has not 

been classified by the OIE as either 

negligible or controlled risk for BSE to 

submit a request to the Administrator 

for either classification, along with 

documentation sufficient to allow the 

USDA to evaluate whether the region 

meets the criteria for either 

classification. The requirement that 

updated information be submitted every 

year would apply only to countries that 

APHIS has evaluated for BSE risk upon 

the request of those countries and not to 

countries that have already been 

classified as negligible or controlled risk 

by the OIE. 

One commenter noted that in 

proposed § 93.436(b)(2)(iii), the 

proposed regulatory text mentions ‘‘BSE 

minimal risk regions.’’ The commenter 

suggested correcting this to ‘‘region of 

negligible risk for BSE in which there 

has been an indigenous case of BSE/

region of controlled risk for BSE.’’ 

The commenter is correct. We have 

corrected this error in the final rule. 

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2http://www.ers.usda.gov/data-products/meatprice-spreads.aspx. 

3U.S. Census Bureau, as reported by Global 

Information Services, Inc. This is the source of all 

trade data reported here. 

Conditions for Importation of 

Commodities 

Live Animals 

One commenter stated that adopting 

the changes in the proposed rule could 

result in BSE-infected cattle entering the 

United States and cause the loss of 

export markets. Another commenter 

expressed concern that detection of BSE 

in imported cattle could cause domestic 

consumers to lose confidence in beef, 

resulting in economic harm to the U.S. 

cattle industry. 

We disagree with the commenters. We 

will be conducting our own evaluations 

of the date of effective enforcement of 

the feed ban in any region that would 

export live cattle to the United States, 

and we will accept exports of live cattle 

from regions of undetermined risk for 

BSE only on a case-by-case basis when 

the Administrator determines that they 

do not present a risk of introducing BSE 

into the United States. We are confident 

that these and the other risk mitigation 

measures in this rule will be effective at 

preventing BSE-infected cattle from 

being imported into the United States. 

Additionally, we note that economic 

effects of the most recent BSE case in 

the United States, confirmed on April 

24, 2012, in a dairy cow in California, 

were not significant, as evidenced by 

U.S. beef price levels and beef and cattle 

exports. Monthly retail prices of choice 

beef averaged $4.93 per pound for the 

12 months between April 2011 and 

March 2012.2 For the following 12 

months, April 2012 through March 

2013, the average monthly retail price of 

choice beef was $5.03 per pound. 

Comparing narrower time frames, for 

the 4-month period January 2012 

through April 2012, the average 

monthly retail price was $5.04 per 

pound, compared to an average monthly 

price of $4.96 per pound for the 4 

months between May 2012 and August 

2012; that is, choice beef prices over the 

4 months following the BSE discovery 

were less than 2 percent lower than 

prices during the 4 months preceding 

the discovery. A variety of marketing 

factors influence price movements, and 

this small percentage decline in 4- 

month average price levels is well 

within normal market fluctuations. 

With respect to U.S. beef exports, for 

the 12 months before the BSE discovery, 

monthly exports averaged about 71,500 

metric tons (MT), valued at about $383 

million, compared to a monthly average 

of about 64,300 MT, valued at about 

$391 million, during the 12 months 

following the discovery.3 It appears 

unlikely that much of this year-on-year 

quantity decline can be attributed to the 

BSE discovery when one compares 

average monthly U.S. beef export levels 

during the 2 months before and 2 

months after the BSE discovery. The 

quantity of beef exported by the United 

States in March and April, 2012, 

averaged about 63,800 MT per month, 

valued at about $384 million, compared 

to an average for May and June 2012 of 

65,700 MT per month, valued at about 

$394 million. 

U.S. monthly cattle exports averaged 

about 16,700 head, valued at $32.4 

million, during the year preceding the 

2012 BSE discovery, compared to a 

monthly average of about 15,100 head, 

valued at $30.9 million, during the year 

following the BSE discovery. Again, this 

small difference falls well within the 

range of monthly variation. Considering 

only the 2 months before and 2 months 

after the BSE discovery, exports for 

March and April 2012 averaged about 

12,100 head per month, valued at $20.9 

million, compared to about 17,900 head 

per month for May and June 2012, 

valued at $39.0 million. 

One commenter stated that it was 

unclear if the provisions of the proposed 

rule would be applicable to 

domesticated water buffaloes (Bubalus 

bubalis). The commenter stated that the 

definition of ‘‘bovines’’ should be 

extended to include the domesticated 

water buffalo, which is commonly 

raised as a farmed animal in some 

European Union (EU) Member States. 

APHIS disagrees with the commenter 

that the domesticated water buffalo 

should be included in the definition of 

bovines. Current trade in water buffalo 

products is primarily in semen and 

embryos and in dairy products; this rule 

will not affect trade in these articles. 

Three commenters noted that the 

proposed rule addressed only bovines 

and bovine products, and that BSErelated restrictions on ovines and 

caprines were not addressed in the 

proposal. The commenters stated that 

APHIS should publish a rule lifting 

BSE-related restrictions on ovines and 

caprines as soon as possible. One 

commenter specifically requested that 

APHIS remove BSE-related import 

restrictions on ovine casings. 

As we explained in the proposed rule, 

we are in the process of developing a 

proposal to amend the BSE regulations 

as they affect the importation of ovines 

and caprines and products derived from 

those animals. Upon completion of the 

proposal, we will publish it in the 

Federal Register for public comment. 

One commenter asked that APHIS 

reconsider its policy on importation of 

zoo ruminants from Canada. The 

commenter stated that, since zoo 

ruminants cannot be imported from 

Canada, U.S. zoos are reluctant to send 

animals to Canada on breeding loans 

because they cannot get them back. The 

commenter stated that zoo ruminants 

have no history of BSE and will never 

come into contact with any domestic 

livestock in the United States food 

chain, and therefore they pose little, if 

any, risk to U.S. agriculture. The 

commenter stated further that North 

American zoos are losing tremendous 

genetic resources due to the inability to 

exchange hoofstock across the U.S. 

border. The commenter stated that this 

could lead to the collapse of valuable 

captive ruminant populations. 

The commenter is incorrect that zoo 

ruminants have no history of BSE. BSE 

has been reported in several species of 

exotic ruminants, including nyala 

(Tragelaphus angasi), kudu 

(Tragelaphus strepsiceros), gemsbok 

(Oryx gazella), eland (Taurotragus oryx), 

Arabian oryx (Oryx leucoryx), scimitarhorned oryx (Oryx dammah), Ankole 

cattle, and bison (Bison bison). As we 

explained above, we are in the process 

of developing a proposal to amend the 

BSE regulations as they affect the 

importation of ovines and caprines and 

products derived from those animals. 

That proposal will also address the 

importation of zoo ruminants. Upon 

completion of that proposal, we will 

publish it in the Federal Register for 

public comment. 

One commenter requested that APHIS 

add the ear tag system as established in 

the EU as an acceptable means of 

permanent identification. 

While APHIS could recognize an ear 

tag system like the one used in the EU 

as an official identification method, for 

live bovines imported from BSE-affected 

countries we also require a permanent 

identification such as a brand or tattoo. 

For example, we require a CbN brand 

or tattoo on cattle imported from 

Canada. This permanent identification 

allows APHIS to trace an animal back to 

the country of origin in the event that 

the animal shows symptoms of a 

transmissible spongiform 

encephalopathy. 

One commenter noted that the 

proposed rule maintains the current 

policy that any cattle imported from 

Canada be born after March 31, 1999. 

The commenter stated that when this 

requirement was implemented in 2007, 

it was estimated that 11 percent of the 

cattle in Canada were born before that 

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4 Immunohistochemistry and Western blot tests at 

USDA’s National Veterinary Services Laboratories 

confirmed that the most recent case of BSE in the 

United States was atypical BSE, not classical BSE. 

The report of the case investigation can be viewed 

on the APHIS Web site at http://

www.aphis.usda.gov/animal_health/animal_

diseases/bse/downloads/BSE_Summary_

Report.pdf. 

date, but that according to a January 

2012 inventory of cattle in Canada, that 

number is now approximately 2 percent. 

The commenter stated that because this 

number will continue to decline, and 

because classical BSE is mostly found in 

cattle between the ages of 4 and 7 years, 

and is rare in cattle aged over 9 years, 

APHIS should consider eliminating this 

requirement, either by adoption in the 

final rule or by incorporating a 

reasonable sunset provision in the final 

rule. 

APHIS disagrees with the commenter. 

We believe that we should keep the date 

in the regulations because this rule 

recognizes Canada as a controlled risk 

region. Live cattle may be safely 

imported from controlled risk regions 

provided that the cattle were born after 

the date the ruminant-to-ruminant feed 

ban was effectively enforced. In 2007, 

after a thorough evaluation of several 

factors contributing to enforcement and 

compliance of the feed ban, APHIS 

concluded that the Canadian feed ban 

was effectively enforced by March 31, 

1999. 

One commenter noted that while the 

rule removes BSE-related import 

restrictions on in vivo-derived embryos, 

it does not address restrictions on in 

vitro-derived embryos. The commenter 

stated that, consistent with international 

standards, there should be no BSErelated restrictions on either in vivo- or 

in vitro-derived embryos and that 

APHIS should revise the provisions for 

embryos accordingly. 

The commenter is correct that the OIE 

does not recommend restrictions on in 

vitro-derived embryos with respect to 

BSE. Our regulations in § 98.3(h) 

currently require that ruminant and 

swine embryos have an intact zona 

pellucida, which effectively prohibits 

the importation of in-vitro derived and 

processed embryos. This restriction is 

not related to BSE risk, but to the risks 

of other livestock diseases, such as 

bovine viral diarrhea, foot-and-mouth 

disease, infectious bovine 

rhinotracheitis, leptospirosis, leukosis, 

and mycoplasmosis. 

One commenter noted that APHIS 

proposed to amend the definition of 

‘‘recognized slaughter establishment’’ to 

mean a slaughtering establishment 

operating under the provisions of the 

Federal Meat Inspection Act or a State 

meat inspection act. The commenter 

asked for clarification of whether 

‘‘State’’ refers only to States of the 

United States or to territories or nations 

as well. 

The word ‘‘State’’ in this definition 

refers to a State of the United States. 

The definition specifically addresses 

slaughter establishments in the United 

States that are under State inspection 

rather than Federal inspection. Facilities 

in the United States that receive 

imported animals for slaughter must 

operate under the provisions of the 

Federal Meat Inspection Act, and 

overseas facilities approved to export to 

the United States must be approved by 

USDA’s FSIS. 

Feed Bans 

One commenter stated that APHIS has 

been inconsistent in how it 

characterizes the usefulness of the feed 

ban. The commenter stated that APHIS 

now argues that the feed ban serves a 

different role in BSE mitigation than 

does SRM removal, and denies that its 

current requirement that animals from 

which eligible beef exports are derived 

must be subject to a feed ban is to 

prevent the importation of products 

derived from Canadian cattle that had 

been exposed to BSE infectivity. The 

commenter stated that APHIS is positing 

either that the feed ban serves no role 

in protecting human health, or that the 

feed ban’s effectiveness in ensuring that 

food entering the food chain is not 

derived from infected animals is 

nonessential to human health. 

APHIS believes that the ruminant-toruminant feed ban serves an important 

role in ensuring that live animals are not 

exposed to the BSE agent, which helps 

ensure that the disease does not appear 

in the U.S. cattle population. SRM 

removal mitigates risk in meat products. 

Our BSE risk assessments examine the 

five barriers that must be compromised 

before BSE could be introduced into the 

U.S. cattle population: U.S. import 

restrictions; slaughter controls; 

rendering inactivation factors; feed 

manufacturing controls; and dose 

response. We consider that any feed ban 

may not have perfect compliance but if 

the risk of release were to be negligible, 

the likelihood of amplification or 

perpetuation within the system would 

also be considered insignificant. As no 

indigenous cases of classical BSE 4 have 

ever been detected in the United States, 

APHIS remains confident that the risk of 

release and exposure to BSE in the 

United States remains negligible. 

One commenter stated that the feed 

ban requirements do not specify how 

long after the date of effective 

enforcement live cattle may be 

imported. The commenter suggested 

that allowing the importation of live 

cattle too soon after the date of effective 

enforcement could result in BSEexposed cattle entering the United 

States. The commenter also stated that 

it was unclear whether the proposal to 

require documentation of effective 

enforcement of feed bans would actually 

provide greater protection against a BSE 

introduction. 

The feed ban requirements apply to 

animals born at any time after the date 

of effective enforcement. APHIS notes 

that at present, the certification 

statement must only say that the 

animals were born after the effective 

enforcement of a feed ban; by requiring 

documentation of the date of effective 

enforcement, we will be better able to 

verify that the bovines were in fact born 

after that date. 

One commenter stated that our 

proposed standards for determining the 

date of effective enforcement of a feed 

ban represent an unnecessary burden 

because the effectiveness of feed ban 

enforcement is already assessed as part 

of the OIE procedure for determining 

the risk status of a country. The 

commenter suggested that instead of 

using a rulemaking process, APHIS 

should either accept the dates 

recognized by the EU, or allow, without 

a rulemaking for the determination of 

the date of effective enforcement of a 

feed ban, cattle born after the date of 

classification of the country. 

In the event that an EU Member State 

wishes to export live cattle to the United 

States, APHIS will consider using the 

date recognized by the EU of effective 

enforcement of the feed ban in that 

Member State after evaluating publicly 

available data or data provided by the 

EU Member State to support such 

recognition. If the data supports the EUrecognized date of enforcement, then 

APHIS will accept such date as the date 

the ruminant-to-ruminant feed ban was 

effectively enforced in the region. For 

other regions, APHIS will make a 

determination based on the information 

received from the country, which can 

also include the specific date of feed 

ban enforcement considered by the 

country or region. 

One commenter stated that 

determination of the date of effective 

enforcement of the ruminant-toruminant feed ban should be a matter 

for the OIE, not for the United States. 

The OIE ad hoc group evaluation does 

not determine the date of feed ban 

enforcement. The OIE assesses whether 

the feed ban was effectively enforced 

through audit and compliance for a 

particular period of time. For controlled 

risk countries, this time period is for 

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5Application for a permit must be filed on VS 

Form 16–3 (available from APHIS, Veterinary 

Services, National Center for Import and Export, 

4700 River Road Unit 38, Riverdale, MD 20737– 

1231, or electronically at http://

www.aphis.usda.gov/animal_health/permits/). The 

application must state the intended use of the 

material and the name and address of the consignee 

in the United States. 

less than 8 years, and for negligible risk 

countries, it is for at least 8 years. 

The commenter stated that there are 

dates generally accepted for the effective 

enforcement of the feed ban in the UK 

(August 1, 1996) and the EU (January 1, 

2001). The commenter asked if APHIS 

will accept these dates. 

As we explained above, in the event 

that an EU Member State wishes to 

export live cattle to the United States, 

APHIS will consider using the date of 

effective enforcement of the feed ban 

recognized by the EU after evaluating 

publicly available data or data provided 

by the EU Member State to support such 

recognition. If the data supports the EUrecognized date of enforcement, then 

APHIS will accept that date as the date 

the ruminant-to-ruminant feed ban was 

effectively enforced in the Member 

State. For other regions, APHIS will 

make a determination based on the 

information received from the country, 

which can also include the specific date 

of feed ban enforcement considered by 

the region. 

Edible and Inedible Products 

One commenter asked if the 

conditions applying to deboned skeletal 

muscle in § 94.18(b)(2) would also apply 

to meat food products and byproducts 

made from deboned skeletal meat and 

containing no restricted commodities. 

The conditions for deboned skeletal 

muscle will apply to meat food products 

made from such, but, as we explained 

in the proposed rule, imported products 

must meet all relevant agency 

requirements, including those of FSIS 

and the U.S. Food and Drug 

Administration (FDA). Each agency has 

the capability to deny imports based on 

their individual authorities and 

concerns. 

One commenter stated that the 

proposed rule reaffirms in § 94.25(a)(2) 

that ovine or caprine meat can derive 

only from animals that were less than 12 

months of age when slaughtered. The 

commenter stated that the OIE Code 

does not recommend any restrictions on 

the import of sheep and goat meat with 

respect to BSE or scrapie. The 

commenter asserted that the restriction 

is unjustified and asked APHIS to 

confirm that it will be removed in a 

future rulemaking. 

As we explained above, we are in the 

process of developing a proposal to 

amend the BSE regulations as they affect 

the importation of ovines and caprines 

and products derived from those 

animals. Upon completion of that 

proposal, we will publish it in the 

Federal Register for public comment. 

One commenter noted that in 

proposed § 94.23(b), we proposed to 

allow the importation of gelatin derived 

from hides and skins regardless of BSE 

risk classification of the region of origin. 

The commenter asked why, then, in 

§§ 94.23(e) and 95.7(e), that the 

certificate accompanying these 

commodities is required to indicate the 

BSE risk category for the exporting 

region. The commenter also asked what 

a region not yet classified should 

indicate on the certificate. The 

commenter suggested using the 

language of § 95.8(e) for tallow with 0.15 

percent of insoluble impurities. 

As we explained in the proposed rule, 

gelatin and collagen derived from hides 

and skins do not present a risk for the 

transmission of BSE. We believe, 

however, that additional risk 

mitigations are warranted for gelatin 

and collagen derived from bones, based 

on the risk classification of the region of 

origin. For this reason we are requiring 

gelatin and collagen imported into the 

United States be accompanied by an 

original certificate that indicates the 

BSE risk classification of the exporting 

region and that states that the required 

conditions have been met. Regions not 

yet classified for BSE risk are 

considered to be regions of 

undetermined risk. We agree with the 

commenter, however, that requiring 

hide-derived gelatin and collagen to 

indicate the BSE risk category for the 

exporting region is unwarranted if the 

products can be demonstrated to be 

hide-derived and have amended 

§§ 94.23(e) and 95.7(e) accordingly. 

The commenter asked APHIS to 

elaborate on the circumstances where 

the provision for gelatin and collagen 

from bones that will have no contact 

with ruminants in the United States 

could be imported, and under what 

conditions the gelatin or collagen would 

be allowed importation. 

APHIS believes that the rule is clear 

in what the criteria are for importing 

gelatin and collagen; specifically, such 

products may be imported if the 

Administrator determines that the 

gelatin and collagen will not come into 

contact with ruminants in the United 

States and that the conditions under 

which it will be imported will prevent 

the introduction of BSE into the United 

States. Examples of these uses would 

include products for human or 

industrial use, such as film, cosmetics, 

manufacturing for glue purposes, and so 

on. Persons wishing to import gelatin 

and collagen would also need to obtain 

a United States Veterinary Permit for the 

Importation and Transportation of 

Controlled Materials and Organisms and 

Vectors,5 and the uses would have to be 

stated on the permit application. The 

importation of gelatin and collagen 

intended solely for human use must still 

meet the requirements established by 

other agencies that regulate for public 

health. 

One commenter stated that the 

definition of ‘‘offal’’ in § 95.1 leads the 

reader to believe that offal is exclusively 

inedible in the United States and will 

not be allowed to be imported for 

human consumption. The commenter 

stated that this is not true and that it is 

well known that liver, tripe, and other 

organ meats are found on the U.S. 

market. The commenter asked that we 

clarify that meat by-products may 

include edible parts of a butchered 

animal, including brains, thymus, 

pancreas, liver, heart, and kidneys. The 

commenter also asked that we define in 

§ 94.0 what products are included in 

‘‘meat by-products’’ and amend the 

definition of offal in § 95.1 to make it 

clear that the parts mentioned, when 

edible, are not covered by the definition. 

FSIS, which has the primary authority 

for regulating meat and meat products 

intended for human consumption, does 

not define offal but does refer to 

products such as organ meats as ‘‘meat 

by-products’’ when used for human 

consumption. However, we agree with 

the commenter that the definition of 

‘‘offal’’ in § 95.1 may be confusing and 

have revised it to read ‘‘the inedible 

parts of a butchered animal.’’ 

One commenter noted that the 

proposed rule says that APHIS concurs 

with OIE’s recommendations regarding 

trade of dicalcium phosphate. The 

commenter stated that Article 11.5.17 of 

the OIE Code recommends the same 

conditions for dicalcium phosphate 

originating in regions of controlled or 

undetermined risk, and that APHIS 

should justify its reasons for prohibiting 

dicalcium phosphate from regions of 

undetermined risk. 

The commenter is correct that the OIE 

Code recommends no BSE-related 

restrictions for dicalcium phosphate 

that is free of protein or fat. However, 

the OIE Code does recommend that 

dicalcium phosphate that is not free of 

protein or fat should originate only in 

negligible risk or controlled risk regions, 

and that, if the material originates in a 

region of controlled risk for BSE, 

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additional risk mitigation measures be 

applied. Furthermore, as we explained 

in the proposed rule, there is evidence 

that dicalcium phosphate produced 

from bones under normal manufacturing 

processes can contain a small residual 

proteinaceous fraction, and would 

therefore present a risk of transmission 

for BSE. For these reasons we proposed 

to limit the importation of dicalcium 

phosphate that is not free of traces of 

protein or fat from regions of 

undetermined risk to a case-by-case 

basis when the Administrator 

determines that the dicalcium 

phosphate will not come into contact 

with ruminants in the United States and 

can be imported under conditions that 

will prevent the introduction of BSE. 

We have amended the regulatory text in 

§ 95.10 to make these requirements 

clearer. 

One commenter stated that the OIE 

Code does not provide any conditions 

for the importation of tallow from 

regions of undetermined risk other than 

tallow with a maximum level of 

insoluble impurities of 0.15 percent in 

weight and derivatives made from this 

tallow, which are considered safe 

commodities. The commenter stated 

that APHIS’ proposed prohibition on 

tallow other than tallow with maximum 

level of insoluble impurities of 0.15 

percent in weight from regions of 

undetermined risk would not make 

sense from a technical point of view. 

The commenter stated that APHIS 

should either apply the same conditions 

for the same product from regions of 

controlled risk or justify why it intends 

to prohibit the importation of tallow 

other than tallow with maximum level 

of insoluble impurities of 0.15 percent 

in weight from regions of undetermined 

risk. 

While the OIE Code does recommend 

unrestricted trade in tallow with a 

maximum level of insoluble impurities 

of 0.15 percent, the Code also 

recommends that tallow with more than 

0.15 percent of insoluble impurities by 

weight requires certification that it is 

sourced from a negligible risk country 

or, if it is sourced from a controlled risk 

country, that it is derived from cattle 

that have passed ante-mortem and postmortem inspections and does not 

contain SRMs. We will allow all tallow 

if it is determined that it will not come 

in contact with ruminants, for example, 

if the tallow is intended for use in 

manufacturing candles and soaps. The 

importation of tallow intended solely 

for human use must still meet the 

requirements established by other 

agencies that regulate for public health. 

One commenter noted that we 

proposed to prohibit the importation of 

processed animal protein from regions 

of controlled risk for BSE unless it can 

be demonstrated that the product has 

not been commingled or contaminated 

with ruminant meat and bone meal or 

greaves. The commenter stated that the 

second and third options presented in 

§ 95.5(a) are compatible with an export 

region of controlled and even 

undetermined risk, but that the 

certificate required in § 95.5(b) must 

state that the exporting region is of 

negligible risk. The commenter asked 

APHIS to clarify what risk statuses are 

allowed for both the exporting regions 

and the regions in which the ruminants 

from which the processed animal 

protein is derived are born and raised, 

and what the restrictions are in each 

case. The commenter also stated that the 

certificate should be able to 

accommodate each available option. 

APHIS agrees with the commenter. 

Our intention is to allow processed 

animal protein from all regions if it can 

be demonstrated that the products are 

not contaminated with prohibited 

material, i.e. ruminant meat-and-bone 

meal and greaves or SRMs. Most of 

these products, if not all, would need an 

import permit once it has been 

demonstrated to APHIS that these 

products do not contain prohibited 

material. We have amended § 95.5(a) 

and (b) to clarify this. We have also 

amended § 95.13 and § 95.14(g) to 

require that nonruminant processed 

animal proteins imported from any 

region would have to be accompanied 

by an original certificate and an import 

permit that indicates that the material is 

of nonruminant origin. 

In addition, we have amended 

§§ 94.19, 94.20, and 95.5 to remove the 

requirement that the commodities be 

derived from bovines that were born 

and raised in regions of negligible or 

controlled risk for BSE, respectively. 

The OIE risk assessment evaluation 

takes into consideration the risk of 

release (importation of cattle and cattle 

products for a particular time period) 

and the exposure (likelihood that 

potentially contaminated/infected cattle 

derived product contain the BSE agent 

could be recycled into the system). OIE 

importation standards for countries 

recognized as either negligible or 

controlled risk for BSE take into 

consideration that the risk of importing 

particular commodities (including live 

cattle) has already been mitigated and as 

such contributed to an insignificant risk. 

For this reason, we do not believe the 

requirement that the products be 

derived from bovines born and raised in 

regions of negligible or controlled risk is 

necessary. Instead, we will only require 

that these commodities be exported 

from regions of negligible or controlled 

risk for BSE, respectively, and, in the 

case of processed animal proteins, that 

the commodity has not been 

commingled or contaminated with meat 

and bone meal or greaves from a region 

of controlled or undetermined risk for 

BSE. 

In the proposed rule, we noted that, 

of the types of animal products derived 

from bovines, processed ruminant 

protein that either contains or has been 

contaminated by the BSE agent is the 

means of transmission of BSE. 

Therefore, in conducting an assessment 

of the BSE risk in a country, it is 

important to know the origin of 

processed animal protein, or feedstuffs 

containing processed animal protein, 

that have been imported into the 

country. Processed animal protein 

originating from high-risk countries for 

BSE presents a higher release risk than 

that originating from low-risk countries. 

One commenter asked for clarification 

of the term feedstuffs, and asked 

specifically if it applies only to feed 

intended for livestock or is used in a 

broader sense to apply to pet foods as 

well. 

Yes, the term feedstuffs could apply 

to pet foods as well as livestock feed. It 

is possible that pet foods could be used 

for cattle feed, either by accidental 

misfeeding of pet foods to cattle or by 

misusing salvage pet food for cattle. 

Farms that raise multiple species (e.g. 

dogs, swine, and cattle) present a 

particular risk for misfeeding. We would 

consider both the origin of pet food and 

pet food ingredients, and the likelihood 

of exposure through misfeeding or the 

likelihood of misuse of salvage pet food 

when evaluating a region for BSE risk. 

Specified Risk Materials 

Three commenters expressed concern 

that while the OIE requires removal of 

SRMs from animals older than 30 

months of age, the proposed rule calls 

for removal of SRMs from animals 30 

months of age or older. The commenters 

stated that while this may not appear to 

be a significant difference, it will still 

have a major impact on trade. One 

commenter noted that the EU uses the 

OIE wording and would not be able to 

guarantee compliance with the 

proposed rule. Another commenter 

noted that the use of ‘‘thirty months of 

age or older’’ is consistent with FDA 

regulations and with the rules of Canada 

and Mexico, and stated that adopting 

the OIE’s language in this rulemaking 

would be helpful only if the FDA, 

Canada, and Mexico also adopted it. 

The commenter suggested that a 

possible solution would be for USDA 

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and FDA to develop an equivalency 

agreement with the OIE/EU. 

The commenter is correct that the use 

of ‘‘thirty months of age or older’’ is 

consistent with FSIS and FDA 

regulations as well as with Canadian 

regulations. We note that anyone 

wishing to import bovine products into 

the United States would have to meet 

FSIS or FDA requirements as well as 

APHIS requirements. We do not 

anticipate that this difference will have 

a significant impact on trade. 

One commenter expressed concern 

that the definitions of SRMs in the 

proposed rule are not consistent with 

those in the FDA interim rule ‘‘Use of 

Materials Derived from Cattle in Human 

Food and Cosmetics’’ (69 FR 42256– 

42274, Docket No. 2004N–0081) and the 

FDA proposed rule ‘‘Use of Materials 

derived from Cattle in Medical Products 

Intended for Use in Humans and Drugs 

Intended for Use in Ruminants’’ (72 FR 

1582–1619, Docket No. 2005N–0373). 

The commenter stated that while the 

APHIS’ proposed rule would allow for 

the importation of some bovine gelatins, 

the same bovine gelatins would be 

prohibited on the U.S. market under the 

FDA rules, or could not further be 

exported outside the United States due 

to the inconsistency between the 

regulations. 

As we explained in the proposed rule, 

APHIS is adopting the definition of 

SRMs already established by FSIS. 

APHIS and FSIS carry out their 

programs in close coordination with the 

FDA. The USDA coordinates with 

FDA’s Center for Veterinary Medicine 

regarding animal feed and veterinary 

pharmaceuticals; the Center for Food 

Safety and Applied Nutrition regarding 

foods other than meat, poultry, and egg 

products; and other Centers regarding 

drugs, biologics, and devices containing 

bovine material. These agencies 

collaborate, issuing regulations under 

their respective authorities. Imported 

products must meet all relevant agency 

requirements. Each agency has the 

capability to deny imports based on 

their individual authorities and 

concerns. 

One commenter suggested that in the 

proposed definitions for ‘‘region of 

controlled risk for bovine spongiform 

encephalopathy (BSE)’’ and ‘‘region of 

negligible risk for bovine spongiform 

encephalopathy (BSE)’’ in § 92.1, the 

wording ‘‘the same feed that potentially 

contained SRM material’’ be rephrased 

as ‘‘the same potentially contaminated 

feed.’’ The commenter stated that this 

rephrasing would more closely align 

with international standards the 

provisions for identifying and 

controlling the movements of bovines 

that, during their first year of life, were 

reared with a bovine determined to be 

infected with BSE during its first year of 

life. 

We agree with the commenter and 

have made those suggested changes in 

this final rule. 

One commenter stated that the 

requirements in proposed § 94.23 for the 

importation of bone-derived gelatin are 

different from the requirements in 

FDA’s interim final rule ‘‘Use of 

Materials Derived From Cattle in 

Human Food and Cosmetics’’ (70 FR 

53063–53069 and 73 FR 20785–20794, 

Docket No. FDA–2004–N–0188) and 

also the provisions in FDA’s proposed 

rule ‘‘Use of Materials Derived From 

Cattle in Medical Products Intended for 

Use in Humans and Drugs Intended for 

Use in Ruminants’’ (72 FR 1582–1619, 

Docket No. 2005N–0373). The 

commenter stated that under the 

provisions of our proposed rule, gelatin 

imported from regions of controlled or 

undetermined BSE risk would have to 

be manufactured from bovine bones free 

from skulls of animals of all ages, but 

that FDA’s SRM definition allows the 

use of skulls of animals below 30 

months of age. The commenter was 

concerned that some gelatin that could 

be imported under APHIS’ regulations 

could not be used within the United 

States under the provisions of FDA’s 

requirements. 

The commenter is correct that under 

FDA’s interim final rule pertaining to 

human food and cosmetics, imported 

gelatin must not be manufactured from 

skulls and vertebral columns from cattle 

30 months of age or older, regardless of 

the OIE BSE risk categorization of the 

exporting country. FDA’s regulations 

that govern the manufacture of gelatin 

and collagen are found at 21 CFR 189.5 

and 21 CFR 700.27. FDA’s regulations in 

§ 189.5(e) do allow a process for 

designating countries as exempt from 

the restrictions contained in the 

regulations. A country seeking 

designation must send a written request 

to the Office of the Center Director, 

Center for Food Safety and Applied 

Nutrition. FDA will respond in writing 

to any such request and may impose 

conditions in granting any such request. 

The medical products proposed rule 

that FDA published in 2007 would have 

the same restrictions for gelatin in 

medical products intended for use in 

humans, and drugs intended for use in 

ruminants. FDA has not finalized the 

medical products proposed rule. 

One commenter expressed concern 

that APHIS’ list of SRMs differs from the 

OIE list and the EU list. The commenter 

noted especially the inclusion of the 

trigeminal ganglia in the list of SRMs 

and asked APHIS to explain why the 

trigeminal ganglia were included. 

As we explained in the proposed rule 

and in supporting scientific 

documentation, APHIS is adopting the 

definition of SRMs already established 

by FSIS. FSIS has designated as SRMs 

the brain, skull, eyes, trigeminal ganglia, 

spinal cord, vertebral column 

(excluding the vertebrae of the tail, the 

transverse process of the thoracic and 

lumbar vertebrae, and the wings of the 

sacrum), and dorsal root ganglia of cattle 

30 months of age or older, and the 

tonsils and distal ileum of the small 

intestine of all cattle because these 

tissues have demonstrated BSE 

infectivity. 

One commenter stated that APHIS’ 

list of SRMs is stricter than FSIS’ list 

with respect to regions of undetermined 

risk in that the SRM list applies at 12 

months instead of 30. The commenter 

asked if this list would supersede FSIS’ 

for commodities imported from regions 

of undetermined risk. 

The list of SRMs in our proposed rule 

is consistent with FSIS’ list; however, 

the commenter is correct that we 

proposed that the SRM removal 

requirements apply to cattle 12 months 

of age and older from undetermined risk 

regions. This requirement is consistent 

with the OIE recommendations for the 

importation of meat and meat products 

from regions of undetermined risk. If an 

undetermined risk region wants to 

export beef to the United States then the 

product must meet the requirements of 

this rule for removal of SRMs. 

Blood and Blood Products 

Three commenters raised concerns 

about the proposed requirements for 

blood and blood products. The 

commenters stated that neither OIE nor 

EU regulations require that blood be 

collected in a hygienic manner. The 

commenters also stated that the OIE 

recommendation that blood be collected 

from cattle which were not subject to a 

stunning process, prior to slaughter, 

with a device injecting compressed air 

or gas into the cranial cavity, or to a 

pithing process is meant to prevent the 

contamination of the blood with SRMs. 

One commenter stated that the 

additional requirement that blood be 

collected in a hygienic manner was 

therefore unjustified and that APHIS 

should either remove the requirement or 

provide further justification and details 

regarding what the Administrator would 

consider a hygienic manner to collect 

blood at slaughter. The other two 

commenters stated that the inclusion of 

dried plasma and blood products in the 

definition of ‘‘processed animal 

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proteins’’ was inconsistent with Chapter 

11.5 of the OIE Code. 

While we agree with the OIE 

recommendations, we also recognize 

that there are various methods that can 

be used for blood collection. It is not our 

intent to dictate which methods can be 

used, but it must be demonstrated that 

the method used in any given case does 

not result in contamination of the blood 

with SRMs. We recognize blood being 

collected in a closed system as one such 

method. 

APHIS included dried plasma and 

other blood products in the definition of 

‘‘processed animal proteins’’ to allow 

the agency to address the potential of 

such products to be commingled with 

materials that would be prohibited. 

One commenter stated that APHIS 

should provide details regarding what 

the Administrator would consider to be 

a hygienic manner to collect blood from 

live donors. 

The risk with blood collection at 

slaughter is potential contamination of 

the blood with SRMs through brain 

emboli or cross-contamination after 

slaughter. While these risks are not 

associated with the collection of blood 

from live donors, we want to ensure that 

there is no cross-contamination in the 

collection process with blood from 

slaughtered animals that was not 

collected via a closed system or some 

other hygienic method. In our 

September 2007 final rule, we 

recognized a closed system as one 

hygienic method of blood collection 

from live donors. 

One commenter stated that proposed 

§ 95.5 appears internally inconsistent 

with proposed § 95.12 on the subject of 

blood and blood products. 

The commenter is mistaken. Section 

95.5 refers to processed animal proteins 

derived from ruminants. Section 95.12 

refers to bovine blood and products 

derived from bovine blood. These are 

different commodities and represent a 

different risk with respect to BSE. 

One commenter asked why, in 

§ 95.15(b), which contains provisions 

for processed animal proteins from 

nonruminants, it was necessary to 

exempt eligible blood meal, blood 

plasma, and other blood products from 

the prohibition. The commenter stated 

that it seemed contradictory for 

processed animal proteins derived from 

nonruminants to possibly contain 

protein from ruminant blood. The 

commenter stated that either the 

product is a processed animal protein 

from nonruminants and does not 

include any ruminant origin protein, or 

it should be designated as a mixed 

processed animal protein from 

nonruminants and ruminants. 

We note that these provisions actually 

appear in § 95.14(c), not § 95.15(b), and 

disagree that they are contradictory. 

APHIS wants to ensure that 

nonruminant processed animal protein 

mixed with products derived from 

ruminant blood meets the requirements 

we have for blood and blood products 

derived from bovines. 

Date of Effective Enforcement of Feed 

Ban in Mexico 

In the proposed rule, we announced 

that we had conducted an evaluation to 

determine the date of effective 

enforcement of a feed ban in Mexico, 

and that based on that evaluation, we 

consider the date of effective 

enforcement of a feed ban in Mexico to 

be November 30, 2007. We received no 

comments on either the evaluation or on 

the date of effective enforcement on the 

feed ban in Mexico. Therefore, we are 

recognizing November 30, 2007, as the 

date of effective enforcement of the feed 

ban in Mexico in this document. 

Miscellaneous Changes 

One commenter noted that proposed 

§ 95.4(c)(7) refers to ‘‘the conditions of 

paragraphs (d)(1) through (d)(5) of this 

section.’’ The commenter asked if the 

reference should be to paragraphs (c)(1) 

through (c)(5) of the section instead. 

The commenter is correct. We have 

corrected the reference in this final rule. 

We proposed in § 92.7 to incorporate 

by reference Article 11.6.22 of the OIE 

Code, effective 2009. This article of the 

OIE Code sets out guidelines for 

surveillance activities related to BSE. 

We are updating this to incorporate by 

reference Article 11.5.22 of the OIE 

Code, effective 2013. In 2013, the OIE 

updated these guidelines to adjust the 

surveillance points required for risk 

status recognition of countries with 

small populations of cattle. The OIE 

made these changes at the request of the 

BSE ad hoc group, supported by the 

scientific commission and endorsed by 

the OIE member states. 

We proposed in § 94.27(a) to require 

that, meat, meat products, and other 

edible products derived from bovines, 

ovines, or caprines that are otherwise 

prohibited importation into the United 

States may transit ports in the United 

States for immediate export, or transit 

the United States by overland transport 

if certain conditions were met. We have 

decided to remove the requirement that 

the person moving these articles must 

obtain a United States Veterinary Permit 

for Importation and Transportation of 

Controlled Materials and Organisms and 

Vectors. We have also amended the 

transit shipment requirements in § 95.15 

to remove the permit requirement for 

prohibited articles transiting air and 

ocean ports in the United States for 

immediate export. We are making these 

changes in order to be consistent with 

the existing requirements for meat and 

other products of ruminants and swine 

in § 94.15(d). 

Issues Outside the Scope of the 

Rulemaking/Outside APHIS Authority 

One commenter stated that the 

Geographical BSE Risk rating (GBR) for 

the United States should be raised 

because there are many different prion 

strains present in North America and 

those strains are spreading and 

mutating. 

The GBR is a qualitative indicator of 

the likelihood of the presence of one or 

more cattle within the native population 

of a country being infected with BSE, 

pre-clinically as well as clinically, at a 

given point in time. Where its presence 

is confirmed, the GBR gives an 

indication of the level of infection. The 

GBR methodology was developed, and 

is used, by the European Commission as 

the basis for trade legislation rules for 

cattle and their products. APHIS is not 

involved with this process. 

One commenter stated that under 

APHIS’ proposed rule, no bovine tissues 

from a negligible risk region are 

considered to be SRMs. The commenter 

asked why a negligible risk region 

willing to export products other than 

skeletal meat should have to 

demonstrate to FSIS that its BSE risk 

status can be reasonably expected to 

provide the same level of protection 

from human exposure to the BSE agent 

as prohibiting SRMs for use as human 

food does in the United States. The 

commenter stated that this provision 

should be removed or amended to bring 

the regulations in line with 

international standards, and that APHIS 

should coordinate with FSIS toward 

that end. The commenter also asked 

what information should be provided to 

FSIS, and what would be the decision 

procedure, should the provision remain 

unchanged. The commenter asked if this 

demonstration would be required even 

if the exported cuts do not include any 

of the tissues considered as SRMs in 

regions of controlled or undetermined 

risk. 

The FSIS regulations in 9 CFR 327.2 

provide that, to be eligible to export 

meat and meat products to the United 

States for human consumption, a foreign 

country must be able to certify that it 

meets FSIS requirements. Therefore, 

prior to exporting meat and meat 

products to the United States, countries 

are required to be approved by FSIS as 

having an inspection system equivalent 

to that in the United States. FSIS 

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maintains a list of countries eligible to 

export meat to the United States on its 

Web site at http://www.fsis.usda.gov/

wps/portal/fsis/topics/internationalaffairs/importing-products/eligiblecountries-products-foreignestablishments/eligible-foreignestablishments. In the affirmation of its 

SRM interim rule, published in the 

Federal Register on July 13, 2007 (72 FR 

38700–38730, Docket No. 03–025F), 

FSIS stated that it will also consider 

whether APHIS or FDA imposes any 

BSE-related restrictions on imports from 

the country and, if so, the basis for those 

restrictions when developing 

equivalence criteria. 

One commenter stated that APHIS 

should adopt the same standards 

required by the EU and Japan, including 

mandatory testing for all cattle brought 

to slaughter and banning the feeding of 

blood, manure, and slaughterhouse 

waste to animals. 

As we explained above, BSE 

surveillance programs in the United 

States focus on obtaining quality 

samples from targeted subpopulations 

rather than looking at the entire adult 

cattle population. Cattle typically only 

test positive for BSE when they are in 

the last few months of what can be a 

very long incubation period. Testing all 

animals at slaughter would not improve 

our understanding of disease trend 

because not all the exposed cattle will 

be infected, nor would all infected cattle 

test positive. We continue to believe 

that FDA’s BSE feed regulations are 

science based and appropriate for the 

BSE risk in the United States. 

One commenter stated that the United 

States is covering up the scope of BSE 

and variant Creutzfeldt-Jakob disease 

(vCJD) in the United States by not 

requiring medical professionals to 

report vCJD cases and not allowing 

individual producers to test for BSE. 

Requiring medical professionals to 

report vCJD cases is outside of APHIS’ 

statutory authority. With respect to 

individual producers testing for BSE, we 

note that for a diagnostic test to be 

considered valid anywhere in the world, 

it must be done by the competent 

veterinary authority of the national 

government of the region where the 

animals are kept. Furthermore, as we 

explained above, increased testing 

would not provide better understanding 

of disease trend, nor would it provide 

better protection against the spread of 

the disease. 

Three commenters stated that APHIS 

should also harmonize its other import 

regulations, especially those for footand-mouth disease (FMD), with OIE 

standards. 

Amending our other import 

regulations for consistency with OIE 

standards is outside the scope of this 

rulemaking. 

Therefore, for the reasons given in the 

proposed rule and in this document, we 

are adopting the proposed rule as a final 

rule, with the changes discussed in this 

document. Additionally, we are 

adopting as final our preliminary BSE 

risk classifications of countries that 

were announced in the proposed rule, 

and we are recognizing November 30, 

2007, as the date of effective 

enforcement of a feed ban in Mexico. 

Executive Orders 12866 and 13563 and 

Regulatory Flexibility Act 

This final rule has been determined to 

be significant for the purposes of 

Executive Order 12866 and, therefore, 

has been reviewed by the Office of 

Management and Budget. 

We have prepared an economic 

analysis for this rule. The economic 

analysis provides a cost-benefit analysis, 

as required by Executive Orders 12866 

and 13563, which direct agencies to 

assess all costs and benefits of available 

regulatory alternatives and, if regulation 

is necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, and equity). Executive Order 

13563 emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. The 

economic analysis also provides a final 

regulatory flexibility analysis that 

examines the potential economic effects 

of this rule on small entities, as required 

by the Regulatory Flexibility Act. The 

economic analysis is summarized 

below. Copies of the full analysis are 

available on the Regulations.gov Web 

site (see footnote 1 in this document for 

a link to Regulations.gov) or by 

contacting the person listed under FOR

FURTHER INFORMATION CONTACT. 

This rule will make our bovine and 

bovine product import restrictions 

related to BSE more reflective of current 

scientific thinking while continuing to 

guard against the introduction of BSE. 

The process for classifying regions with 

respect to BSE risk will be based on the 

comprehensive review of relevant, 

internationally accepted scientific 

literature and will be consistent with 

the process employed by the OIE. The 

rule will also remove BSE-related 

restrictions on the importation of live 

cervids and camelids and their 

products. 

While benefits of the rule are 

expected to justify its costs, effects on 

U.S. imports are expected to be 

minimal. Potential impacts of the rule 

on U.S. export markets, by influencing 

trading partners’ import policies, are not 

considered in this analysis. 

Live Bovines (Cattle and Bison) 

Essentially all U.S. imports of cattle 

and bison are from Canada and Mexico. 

Over the 10 years 2002–2011, the only 

live bovine imports that did not come 

from Canada or Mexico were 33 animals 

from Australia, 12 from New Zealand, 

and 1 from Guatemala. APHIS is 

classifying Canada and Mexico as 

countries of controlled risk for BSE 

(their classification by the OIE). 

Imports from Canada will be 

unaffected by this rule because the 

requirements will cause no change in 

the number or type of animals that are 

eligible for importation, based on 

Canada’s status as a BSE minimal-risk 

region under APHIS’ existing 

regulations. Imports from Mexico also 

will be essentially unaffected, since 

nearly all cattle imported from Mexico 

(98 to 99 percent) are estimated to be 

less than 24 months of age; with this 

rule APHIS is establishing November 

30, 2007, as the date of effective 

enforcement of a ruminant-to-ruminant 

feed ban in Mexico (the earliest date 

that bovines imported from Mexico 

could be born). 

Products Derived From Bovines 

Six countries, Argentina, Australia, 

Brazil, Canada, New Zealand, and 

Uruguay, accounted for 91 percent of all 

U.S. bovine product import volume (and 

90 percent of the import value) over the 

5-year period 2007–2011. Imports from 

each of the six countries should 

continue essentially unchanged and 

without interruption under the rule, 

because the protocols in place in these 

countries are already in full compliance 

with the rule’s criteria. Argentina, 

Australia, New Zealand, and Uruguay 

will be classified by APHIS as negligible 

risk regions for BSE; they have never 

reported a case of BSE. Canada and 

Brazil, which will be classified by 

APHIS as controlled risk regions for 

BSE, already satisfy FSIS inspection 

requirements and prohibitions on 

certain animal stunning or pithing and 

mechanically separated meat. 

Imports allowed by the rule from the 

36 (primarily European) countries listed 

in 9 CFR 94.18 as prohibited from 

shipping bovine products to the United 

States likely will be insignificant. In 

none of the years from 1990 through 

1996, that is, prior to the prohibition on 

ruminant product imports from all of 

Europe in 1997, did the volume of U.S. 

bovine product imports from the 36 

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72992 Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Rules and Regulations 

6 Go to http://www.regulations.gov/

#!docketDetail;D=APHIS-2008-0010. The 

environmental assessment and finding of no 

significant impact will appear in the resulting list 

of documents. 

countries account for more than 0.6 

percent of imports of these products. 

Nor does recent EU trade in bovine 

products suggest a significant volume of 

imports from the 36 countries in the 

future, at least in the near term. While 

the nominal value of bovine product 

exports by the European Union (EU–27) 

increased more than four-fold in 5 years, 

from $0.36 billion in 2007 to nearly 

$1.57 billion in 2011, the value of 

bovine product imports by EU–27 

Member States in 2011 ($2.42 billion) 

exceeded the value of their bovine 

product exports by more than $850 

million. The EU–27 continues to be a 

large net importer of bovine products 

overall. Emerging markets, such as 

Russia, are likely to take a growing share 

of Europe’s bovine product exports. 

Bovine product imports from other 

countries that are not currently subject 

to BSE-related restrictions are not 

expected to be significantly affected. 

Over the 5 years 2007–2011, annual 

imports from such countries as a group 

averaged 8 to 9 percent of all U.S. 

bovine product imports by volume (10 

to 11 percent by value), with over 95 

percent of these products coming from 

Mexico, Nicaragua, and Costa Rica. 

Imports from Mexico already meet the 

requirements of a region of controlled 

risk for BSE largely by way of FSIS 

requirements. The potential impact on 

imports from Nicaragua and Costa Rica, 

which APHIS is classifying as regions of 

undetermined risk for BSE, should be 

minimal at most. Almost all imports 

from those two countries are of boneless 

beef that already satisfy the rule’s 

requirements, again, largely by way of 

FSIS requirements. 

Live Cervids and Camelids and Their 

Products 

Removal of the prohibition on the 

importation of live cervids and camelids 

and their products from the 36 countries 

listed in 9 CFR 94.18 will likely have 

little or no economic impact on the 

United States. The United States has not 

imported any live cervids or camelids 

from these countries since at least 1990. 

In none of the years from 1990 through 

1996, before the prohibition of ruminant 

meat, meat products, and other edible 

products from all of Europe in 1997, did 

the volume of U.S. imports of meat and 

edible offal of deer from the 36 

countries account for more than 3.3 

percent of total imports. Over the 5 

years 2007–2011, more than 99 percent 

of U.S. imports of meat and edible offal 

of deer have come from New Zealand, 

and that country’s dominance of this 

market is unlikely to change as a result 

of this rule. The volume of U.S. imports 

of camelid products is very small. Their 

annual value averaged less than $50,000 

over the 5-year period 2006–2010 (most 

recent data available), and 90 percent of 

those imports were supplied by Canada 

and China. 

Benefits, Costs, and Alternatives 

Consumers benefit from imports to 

the extent that consumer choice is 

broadened and the increased supply of 

the imported commodity leads to a price 

decline. We anticipate that the rule will 

have little impact on consumer choice 

or import volumes, and therefore little 

or no impact on U.S. businesses as well. 

Although the impact of this rule on 

U.S. consumers and producers is 

expected to be minimal, the benefits of 

the rule are expected to justify its costs. 

Leaving the bovine regulations 

unchanged would be unsatisfactory 

because it would perpetuate the current 

situation in which our BSE-related 

import conditions are not consistent 

with current scientific evidence. 

Additionally, by maintaining the status 

quo APHIS would forgo the opportunity 

to establish a process for classifying a 

region’s BSE risk status in a more timely 

fashion than is possible under current 

regulations. 

Another alternative, amending the 

BSE regulations related to the 

importation of bovines and bovinederived products to match precisely the 

OIE Code would also be unsatisfactory 

because it would not allow APHIS to 

independently interpret the scientific 

literature and findings that underlie OIE 

risk categorization recommendations. 

Making no changes to the regulations 

that govern the importation of cervids 

and camelids would also be 

unsatisfactory because it would 

perpetuate an unnecessary constraint on 

trade in those commodities. 

Effects on Small Entities 

Small entities prevail among the 

industries that may be affected by this 

rule, including cow-calf producers, 

cervid and camelid producers, feedlot 

establishments, slaughtering 

establishments, meat packing and 

processing establishments, meat 

wholesalers, importers and exporters, 

grocery stores and meat markets, and 

manufacturers of cosmetics and 

pharmaceuticals. However, as has been 

described, any changes because of this 

rule in U.S. imports of live bovines, 

cervids, camelids, or their products are 

expected to be minor. U.S. small entities 

are unlikely to be significantly affected. 

This rule contains no mandatory 

reporting, recordkeeping, or other 

compliance requirements for U.S. 

entities. 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule: (1) Preempts 

all State and local laws and regulations 

that are inconsistent with this rule; (2) 

has no retroactive effect; and (3) does 

not require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

National Environmental Policy Act 

An environmental assessment and 

finding of no significant impact have 

been prepared for this final rule. The 

environmental assessment provides a 

basis for the conclusion that the 

importation of live bovines and bovine 

products under the conditions specified 

in this rule will not have a significant 

impact on the quality of the human 

environment. Based on the finding of no 

significant impact, the Administrator of 

the Animal and Plant Health Inspection 

Service has determined that an 

environmental impact statement need 

not be prepared. 

The environmental assessment and 

finding of no significant impact were 

prepared in accordance with: (1) The 

National Environmental Policy Act of 

1969 (NEPA), as amended (42 U.S.C. 

4321 et seq.), (2) regulations of the 

Council on Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508), (3) 

USDA regulations implementing NEPA 

(7 CFR part 1b), and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). 

The environmental assessment and 

finding of no significant impact may be 

viewed on the Regulations.gov Web 

site.6 Copies of the environmental 

assessment and finding of no significant 

impact are also available for public 

inspection at USDA, room 1141, South 

Building, 14th Street and Independence 

Avenue SW., Washington, DC, between 

8 a.m. and 4:30 p.m., Monday through 

Friday, except holidays. Persons 

wishing to inspect copies are requested 

to call ahead on (202) 799–7039 to 

facilitate entry into the reading room. In 

addition, copies may be obtained by 

writing to the individual listed under 

FOR FURTHER INFORMATION CONTACT. 

Paperwork Reduction Act 

In accordance with section 3507(d) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), the information 

collection or recordkeeping 

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Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Rules and Regulations 72993 

1A list of regions classified by APHIS as regions 

of controlled risk for BSEs is available at http://

www.aphis.usda.gov/import_export/animals/

animal_disease_status.shtml. 

requirements included in this final rule, 

which were filed under 0579–0393, 

have been submitted for approval to the 

Office of Management and Budget 

(OMB). When OMB notifies us of its 

decision, if approval is denied, we will 

publish a document in the Federal 

Register providing notice of what action 

we plan to take. 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the Internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this rule, please contact Mrs. Celeste 

Sickles, APHIS’ Information Collection 

Coordinator, at (301) 851–2908. 

List of Subjects 

9 CFR Part 92 

Animal diseases, Imports, 

Incorporation by reference, Livestock, 

Poultry and poultry products, Region, 

Reporting and recordkeeping 

requirements. 

9 CFR Part 93 

Animal diseases, Imports, Livestock, 

Poultry and poultry products, 

Quarantine, Reporting and 

recordkeeping requirements. 

9 CFR Part 94 

Animal diseases, Imports, Livestock, 

Meat and meat products, Milk, Poultry 

and poultry products, Reporting and 

recordkeeping requirements. 

9 CFR Part 95 

Animal feeds, Hay, Imports, 

Livestock, Reporting and recordkeeping 

requirements, Straw, Transportation. 

9 CFR Part 96 

Imports, Livestock, Reporting and 

recordkeeping requirements. 

9 CFR Part 98 

Animal diseases, Imports. 

Accordingly, we are amending 9 CFR 

parts 92, 93, 94, 95, 96, and 98 as 

follows: 

PART 92—IMPORTATION OF ANIMALS 

AND ANIMAL PRODUCTS: 

PROCEDURES FOR REQUESTING 

RECOGNITION OF REGIONS 

■ 1. The authority citation for part 92 

continues to read as follows: 

Authority: 7 U.S.C. 1622 and 8301–8317; 

21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 

CFR 2.22, 2.80, and 371.4. 

■ 2. In § 92.1, definitions of approved 

laboratory, bovine, exporting region, 

OIE, OIE Code, OIE Terrestrial Manual, 

processed animal protein, region of 

controlled risk for BSE, region of 

negligible risk for BSE, region of 

undetermined risk for BSE, specified 

risk materials (SRMs) from regions of 

controlled risk for BSE, and specified 

risk materials (SRMs) from regions of 

undetermined risk for BSE are added in 

alphabetical order to read as follows: 

§ 92.1 Definitions. 

* * * * * 

Approved laboratory. A properly 

equipped institution in the exporting 

region, approved by the official 

authority who is responsible for animal 

health matters in that region, that is 

staffed by technically competent 

personnel under the control of a 

specialist in veterinary diagnostic 

methods who is responsible for the 

results. 

Bovine. Bos taurus, Bos indicus, and 

Bison bison. 

* * * * * 

Exporting region. A region from 

which shipments are sent to the United 

States. 

* * * * * 

OIE. The World Organization for 

Animal Health. 

OIE Code. The Terrestrial Animal 

Health Code of the World Organization 

for Animal Health. 

OIE Terrestrial Manual. The Manual 

of Diagnostic Tests and Vaccines for 

Terrestrial Animals of the World 

Organization for Animal Health. 

* * * * * 

Processed animal protein. Meat meal, 

bone meal, meat-and-bone meal, blood 

meal, dried plasma and other blood 

products, hydrolyzed protein, hoof 

meal, horn meal, poultry meal, feather 

meal, fish meal, and any other similar 

products. 

* * * * * 

Region of controlled risk for bovine 

spongiform encephalopathy (BSE).1 A 

region for which a risk assessment has 

been conducted sufficient to identify the 

historical and existing BSE risk factors 

in the region and that: 

(1) Has demonstrated that appropriate 

mitigations are being taken to manage 

all identified risks, but may not have 

been taken for the periods of time 

necessary to be classified as a region of 

negligible risk for BSE. 

(2) Is a region in which it can be 

demonstrated through an appropriate 

control and audit that neither meat-andbone meal nor greaves derived from 

ruminants has been fed to ruminants. 

(3) Has demonstrated that Type A 

surveillance in accordance with Article 

11.5.22 of the OIE Code, incorporated by 

reference in § 92.7, or with equivalent 

guidelines recognized by the 

Administrator is in place and the 

relevant points target, in accordance 

with Table 1 of Article 11.5.22 of the 

OIE Code, or with equivalent guidelines 

recognized by the Administrator has 

been met. Type B surveillance in 

accordance with Article 11.5.22 of the 

OIE Code, or with equivalent guidelines 

recognized by the Administrator, is 

sufficient in place of Type A 

surveillance or its equivalent once the 

relevant points target for Type A 

surveillance or its equivalent has been 

met. 

(4) Meets one of the following 

conditions: 

(i) Has had no case of BSE in the 

region or every case has been 

demonstrated to have been imported 

and has been completely destroyed; or 

(ii) Has had at least one indigenous 

case, and all bovines described in either 

paragraph (4)(ii)(A) or (4)(ii)(B) of this 

definition, if still alive, are officially 

identified with unique individual 

identification that is traceable to the 

premises of origin of the animal, have 

their movements controlled, and, when 

slaughtered or at death, are completely 

destroyed: 

(A) All bovines that, during their first 

year of life, were reared with a bovine 

determined to be infected with BSE 

during its first year of life, and that 

investigation showed consumed the 

same potentially contaminated feed as 

the infected animal during that period; 

or 

(B) If the investigation was unable to 

determine whether the feed source that 

was used to feed the bovine known to 

be infected was also used to feed other 

bovines in the herd of the infected 

animal, all bovines born in the same 

herd as a BSE-infected bovine either 

within 12 months before or 12 months 

after the birth of the infected animal. 

(5) Meets the conditions in one of or 

both paragraphs (5)(i) or (5)(ii) of this 

definition: 

(i) Has met the following conditions, 

but not for at least the past 7 years: 

(A) Conducted an ongoing awareness 

program for veterinarians, farmers, and 

workers involved in transportation, 

marketing, and slaughter of bovines to 

encourage reporting of bovines showing 

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72994 Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Rules and Regulations 

2A list of regions classified by APHIS as regions 

of negligible risk for BSEs is available at http://

www.aphis.usda.gov/import_export/animals/

animal_disease_status.shtml. 

clinical signs that could be indicative of 

BSE; 

(B) Required notification and 

investigation of all bovines showing 

clinical signs consistent with BSE; and 

(C) Has carried out the examination, 

in accordance with internationally 

accepted diagnostic tests and 

procedures and in approved 

laboratories, of brain or other tissues 

collected as part of the surveillance and 

monitoring described in paragraphs (3) 

and (5)(i)(A) and (5)(i)(B) of this 

definition; or 

(ii) Has prohibited the feeding to 

ruminants in the region of meat-andbone meal and greaves derived from 

ruminants, but it cannot be 

demonstrated through an appropriate 

level of control and audit that the 

prohibited materials have not been fed 

to ruminants in the region for at least 

the past 8 years. 

Region of negligible risk for bovine 

spongiform encephalopathy (BSE).2 A 

region for which a risk assessment has 

been conducted sufficient to identify the 

historical and existing BSE risk factors 

in the region and that: 

(1) Has demonstrated that appropriate 

mitigations to manage all identified 

risks have been taken for each relevant 

period of time to meet each identified 

risk, as set forth in this definition. 

(2) Has demonstrated that Type B 

surveillance in accordance with Article 

11.5.22 of the OIE Code, incorporated by 

reference in § 92.7, or with equivalent 

guidelines recognized by the 

Administrator is in place and the 

relevant points target, in accordance 

with Table 1 of Article 11.5.22 of the 

OIE Code, or with equivalent guidelines 

recognized by the Administrator has 

been met. 

(3) Meets one of the following 

conditions: 

(i) Has had no case of BSE in the 

region or every case has been 

demonstrated to have been imported 

and has been completely destroyed; or 

(ii) Has had at least one indigenous 

case, but every indigenous case was 

born more than 11 years ago, and all 

bovines described in either paragraph 

(3)(ii)(A) or (3)(ii)(B) of this definition, 

if still alive, are officially identified 

with unique individual identification 

that is traceable to the premises of origin 

of the animal, have their movements 

controlled, and, when slaughtered or at 

death, are completely destroyed: 

(A) All bovines that, during their first 

year of life, were reared with a bovine 

determined to be infected with BSE 

during its first year of life, and that 

investigation showed consumed the 

same potentially contaminated feed as 

the infected animal during that period; 

or 

(B) If the investigation was unable to 

determine whether the feed source that 

was used to feed the bovine known to 

be infected was also used to feed other 

bovines in the herd of the infected 

animal, all bovines born in the same 

herd as a BSE-infected bovine either 

within 12 months before or 12 months 

after the birth of the infected animal. 

(4) Has, for at least the past 7 years: 

(i) Conducted an ongoing awareness 

program for veterinarians, farmers, and 

workers involved in transportation, 

marketing, and slaughter of bovines to 

encourage reporting of bovines showing 

clinical signs that could be indicative of 

BSE; 

(ii) Required notification and 

investigation of all bovines showing 

clinical signs consistent with BSE; and 

(iii) Carried out the examination, in 

accordance with internationally 

accepted diagnostic tests and 

procedures and in approved 

laboratories, of brain or other tissues 

collected as part of the required 

surveillance and monitoring described 

in paragraphs (2) and (4)(i) and (4)(ii) of 

this definition. 

(5) Has demonstrated through an 

appropriate level of control and audit 

that, for at least the past 8 years, neither 

meat-and-bone meal nor greaves derived 

from ruminants have been fed to 

ruminants in the region. 

Region of undetermined risk for 

bovine spongiform encephalopathy 

(BSE). Any region that is not classified 

as either a region of negligible risk for 

BSE or a region of controlled risk for 

BSE. 

* * * * * 

Specified risk materials (SRMs) from 

regions of controlled risk for BSE. Those 

bovine parts considered to be at 

particular risk of containing the BSE 

agent in infected animals, as listed in 

the FSIS regulations at 9 CFR 310.22(a). 

Specified risk materials (SRMs) from 

regions of undetermined risk for BSE. 

Those bovine parts considered to be at 

particular risk of containing the BSE 

agent in infected animals, as listed in 

the FSIS regulations at 9 CFR 310.22(a), 

except that the following bovine parts 

from regions of undetermined risk for 

BSE are considered SRMs if they are 

derived from bovines over 12 months of 

age: Brain, skull, eyes, trigeminal 

ganglia, spinal cord, vertebral column 

(excluding the vertebrae of the tail, the 

transverse processes of the thoracic and 

lumbar vertebrae, and the wings of the 

sacrum), and the dorsal root ganglia. 

* * * * * 

■ 3. Subpart A, consisting of existing 

§§ 92.2 through 92.4, is added under the 

following heading: 

Subpart A—Procedures for Requesting 

Recognition of Regions Other Than for 

BSE 

■ 4. Subpart B, consisting of §§ 92.5, 

92.6, and 92.7, is added to read as 

follows: 

Subpart B—Procedures for Requesting BSE 

Risk Status Classification With Regard to 

Bovines 

Sec. 

92.5 Determination of the BSE risk 

classification of a region. 

92.6 Determination of the date of effective 

enforcement of a ruminant-to-ruminant 

feed ban. 

92.7 Incorporation by reference. 

Subpart B—Procedures for Requesting 

BSE Risk Status Classification With 

Regard to Bovines 

§ 92.5 Determination of the BSE risk 

classification of a region. 

All countries of the world are 

considered by APHIS to be in one of 

three BSE risk categories—negligible 

risk, controlled risk, or undetermined 

risk. These risk categories are defined in 

§ 92.1. Any region that is not classified 

by APHIS as presenting either negligible 

risk or controlled risk for BSE is 

considered to present an undetermined 

risk. The listing of those regions 

classified by APHIS as having either 

negligible risk or controlled risk can be 

accessed on the APHIS Web site at 

http://www.aphis.usda.gov/import_

export/animals/animal_disease_

status.shtml. The listing can also be 

obtained by writing to APHIS at 

National Import Export Services, 4700 

River Road Unit 38, Riverdale, MD 

20737. APHIS may classify a region for 

BSE according to either paragraph (a) or 

paragraph (b) of this section. 

(a) BSE risk classification based on 

OIE classification. If the OIE has 

classified a country as either BSE 

negligible risk or BSE controlled risk, 

APHIS will seek information to support 

concurrence with the OIE classification. 

This information could be publicly 

available information, or APHIS could 

request that countries supply the same 

information given to the OIE. APHIS 

will announce in the Federal Register, 

subject to public comment, each intent 

to concur with an OIE classification. 

APHIS will also post the summary of 

the BSE OIE ad hoc group conclusions 

for review during the comment period. 

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Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Rules and Regulations 72995 

The summaries would be available for 

review on the APHIS Web site at 

http://www.aphis.usda.gov/import_

export/animals/reg_request.shtml. 

Following review of any comments 

received, the Administrator will 

announce his or her final determination 

regarding classification of the country in 

the Federal Register, along with a 

discussion of and response to pertinent 

issues raised by commenters. If APHIS 

recognizes a country as either negligible 

risk or controlled risk for BSE, the 

Agency will include that country in a 

list of regions of negligible risk or 

controlled risk for BSE, as applicable, 

that APHIS will make available to the 

public on the Agency’s Web site at 

http://www.aphis.usda.gov/import_

export/animals/animal_disease_

status.shtml. 

(b) Regions seeking classification as 

negligible or controlled risk that have 

not been classified by the OIE. A region 

that has not received classification by 

OIE as either negligible risk or 

controlled risk for BSE and that wishes 

to be classified by APHIS as negligible 

risk or controlled risk must submit to 

the Administrator a request for 

classification, along with 

documentation sufficient to allow 

APHIS to conduct an evaluation of 

whether the region meets the criteria for 

classification. A list of the 

documentation required can be accessed 

on the APHIS Web site at http://

www.aphis.usda.gov/import_export/

animals/reg_request.shtml. If, following 

evaluation of the information submitted, 

the Administrator determines that the 

region meets the criteria for 

classification as negligible risk or 

controlled risk, APHIS will announce 

that determination in the Federal 

Register and will make available to the 

public on the APHIS Web site the 

evaluation conducted by APHIS, as well 

as the information provided by the 

requesting region. APHIS will accept 

public comment on its intent. Following 

review of any comments received, the 

Administrator will announce his or her 

final determination regarding 

classification of the region in the 

Federal Register, along with a 

discussion of and response to pertinent 

issues raised by commenters. 

(c) Retention of classification as either 

negligible risk or controlled risk. (1) As 

required by the OIE for countries 

classified as either negligible risk or 

controlled risk by the OIE, regions 

evaluated by APHIS and classified as 

negligible or controlled risk would need 

to submit updated information to APHIS 

each year. The required information 

includes documentation of the 

following: 

(i) Relevant changes in BSE 

legislation, compared to the previous 

year; 

(ii) The importation into the region 

during the year of cattle, processed 

animal protein, and products containing 

processed animal protein; 

(iii) Audit findings in rendering 

plants and feed mills that process 

ruminant material or material from 

mixed species that contains ruminant 

material, related to the prohibition of 

the feeding to ruminants of processed 

animal protein; 

(iv) Audit findings in rendering plants 

and feed mills that process nonruminant 

material, related to the prohibition of 

the feeding to ruminants of processed 

animal protein; 

(v) Infractions at the types of facilities 

listed above; 

(vi) If and why, in light of the audit 

findings, there has been no significant 

exposure of cattle to the BSE agent 

through consumption of processed 

animal protein of bovine origin; 

(vii) Surveillance efforts; 

(viii) All clinical BSE suspects; and 

(ix) Any new cases of BSE. 

(2) If APHIS at any time determines 

that a region no longer meets the criteria 

for the risk classification it had 

previously received, APHIS will remove 

the region from its list of regions so 

classified. If the OIE determines the 

region no longer meets the criteria for 

the risk classification it had previously 

received, APHIS may concur with the 

OIE determination or may request 

updated information from the region 

and determine whether to concur with 

the OIE decision APHIS will announce 

its intent in the Federal Register and 

accept public comment regarding that 

intent. Following review of any 

comments received, the Administrator 

will announce in the Federal Register 

his or her final determination regarding 

classification of the region, along with a 

discussion of and response to pertinent 

issues raised by commenters. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

§ 92.6 Determination of the date of 

effective enforcement of a ruminant-toruminant feed ban. 

(a) In order for APHIS to determine 

the eligibility of live bovines for 

importation from a region classified as 

BSE negligible risk or BSE controlled 

risk, APHIS must determine the date 

from which a ban on the feeding of 

ruminant material to ruminants has 

been effectively enforced in the region. 

APHIS will base its determination of the 

date of effective enforcement on the 

information included in the dossier the 

region submitted when it requested to 

be classified regarding BSE risk. The 

information APHIS will consider will 

include, but not be limited to: 

(1) Policies and infrastructure for feed 

ban enforcement, including an 

awareness program for producers and 

farmers; 

(2) Livestock husbandry practices; 

(3) Disposition of processed animal 

protein produced from domestic 

bovines, including the feeding of such 

material to any animal species; 

(4) Measures taken to control crosscontamination and mislabeling of feed; 

and 

(5) Monitoring and enforcement of the 

ruminant-to-ruminant feed ban, 

including audit findings in rendering 

plants and feed mills that process 

ruminant material. 

(b) After conducting its evaluation, 

APHIS will announce in the Federal 

Register for public comment the date 

APHIS considers to be the date of 

effective enforcement of a ruminant-toruminant feed ban in the requesting 

region, and will make available to the 

public the evaluation conducted by 

APHIS, as well as the supporting 

documentation. Following review of any 

comments received, the Administrator 

will announce his or her final 

determination in the Federal Register, 

along with a discussion of and response 

to pertinent issues raised by 

commenters. 

§ 92.7 Incorporation by reference. 

(a) Certain material is incorporated by 

reference into this part with the 

approval of the Director of the Federal 

Register under 5 U.S.C. 552(a) and 1 

CFR part 51. To enforce any edition 

other than that specified in this section, 

USDA must publish notice of change in 

the Federal Register and the material 

must be available to the public. All 

approved material is available for 

inspection at the Animal and Plant 

Health Inspection Service (APHIS), and 

is available from the sources listed 

below. For information about the 

availability of this material at APHIS, 

call 301–851–3300 or write to National 

Import Export Services, 4700 River Road 

Unit 38, Riverdale, MD 20737. It is also 

available for inspection at the National 

Archives and Records Administration 

(NARA). For information on the 

availability of this material at NARA, 

call 202-741-6030 or go to http://

www.archives.gov/federal_register/

code_of_federal_regulations/ibr_

locations.html. 

(b) World Organization for Animal 

Health (OIE), 12, rue de Prony 75017 

Paris, France, or email oie@oie.int, 

http://www.oie.int/eng/normes/Mcode/

en_sommaire.htm. 

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(1) Terrestrial Animal Health Code, 

Chapter 11.5–Bovine Spongiform 

Encephalopathy, Article 11.5.22 

(Surveillance activities), 22nd Edition, 

2013. 

(2) [Reserved] 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

PART 93—IMPORTATION OF CERTAIN 

ANIMALS, BIRDS, FISH, AND 

POULTRY, AND CERTAIN ANIMAL, 

BIRD, AND POULTRY PRODUCTS; 

REQUIREMENTS FOR MEANS OF 

CONVEYANCE AND SHIPPING 

CONTAINERS 

■ 5. The authority citation for part 93 

continues to read as follows: 

Authority: 7 U.S.C. 1622 and 8301–8317; 

21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 

CFR 2.22, 2.80, and 371.4. 

■ 6. Section 93.400 is amended by 

adding definitions of exporting region 

and processed animal protein in 

alphabetical order and revising the 

definition of recognized slaughtering 

establishment to read as follows: 

§ 93.400 Definitions. 

* * * * * 

Exporting region. A region from 

which shipments are sent to the United 

States. 

* * * * * 

Processed animal protein. Meat meal, 

bone meal, meat-and-bone meal, blood 

meal, dried plasma and other blood 

products, hydrolyzed protein, hoof 

meal, horn meal, poultry meal, feather 

meal, fish meal, and any other similar 

products. 

* * * * * 

Recognized slaughtering 

establishment. Any slaughtering 

establishment operating under the 

provisions of the Federal Meat 

Inspection Act (21 U.S.C. 601 et seq.) or 

a State meat inspection act.2

* * * * * 

2 See footnote 1. 

§ 93.401 [Amended] 

■ 7. In § 93.401, paragraph (a), the 

second sentence is amended by adding 

the word ‘‘non-bovine’’ before the word 

‘‘ruminant’’ and by removing the 

citation ‘‘§ 94.18(a)(1) or (a)(2)’’ and 

adding the citation ‘‘§ 94.24(a)’’ in its 

place. 

§ 93.405 [Amended] 

■ 8. Section 93.405 is amended as 

follows: 

■ a. In paragraph (a)(4), by removing the 

words ‘‘bovines, sheep, or goats from 

regions listed as BSE minimal-risk 

regions in § 94.18(a)(3) of this 

subchapter’’ and adding the words 

‘‘sheep or goats from Canada’’ in their 

place and by removing the words ‘‘and 

93.436(a)(3) and (b)(4)’’; and 

■ b. In the OMB citation at the end of 

the section, by removing the words 

‘‘numbers 0579–0040, 0579–0165, and 

0579–0234’’ and adding the words 

‘‘numbers 0579–0040, 0579–0165, 

0579–0234, and 0579–0393’’ in their 

place. 

■ 9. Section 93.418 is amended as 

follows: 

■ a. By revising the section heading; 

■ b. By adding paragraph (d); and 

■ c. By adding an OMB citation to the 

end of the section. 

The revision and additions read as 

follows: 

§ 93.418 Cattle and other bovines from 

Canada. 

* * * * * 

(d) In addition to meeting the 

requirements of paragraphs (a) through 

(c) of this section, bovines may be 

imported from Canada only under the 

following conditions: 

(1) The bovines are imported for 

immediate slaughter under § 93.420; or 

(2) The bovines are imported for other 

than immediate slaughter under the 

following conditions: 

(i) The bovines were born after March 

1, 1999, the date determined by APHIS 

to be the date of effective enforcement 

of a ruminant-to-ruminant feed ban in 

Canada; 

(ii) The bovines are imported only 

through a port of entry listed in 

§ 93.403(b) or as provided for in 

§ 93.403(f); 

(iii) The bovines were officially 

identified prior to arriving at the port of 

entry in the United States with unique 

individual identification that is 

traceable to each bovine’s premises of 

origin. No person may alter, deface, 

remove, or otherwise tamper with the 

official identification while the animal 

is in the United States or moving into 

or through the United States, except that 

the identification may be removed at 

slaughter; and 

(iv) The bovines are permanently and 

humanely identified using one of the 

following additional methods: 

(A) A ‘‘CbN’’ mark properly applied 

with a freeze brand, hot iron, or other 

method, and easily visible on the live 

animal and on the carcass before 

skinning. Such a mark must be not less 

than 2 inches nor more than 3 inches 

high, and must be applied to each 

animal’s right hip, high on the tail-head 

(over the junction of the sacral and first 

coccygeal vertebrae); or 

(B) A tattoo with the letters ‘‘CN’’ 

applied to the inside of one ear of the 

animal; or 

(C) Other means of permanent 

identification upon request if deemed 

adequate by the Administrator to 

humanely identify the animal in a 

distinct and legible way as having been 

imported from Canada. 

(3) The bovines are accompanied by a 

certificate issued in accordance with 

§ 93.405 that states, in addition to the 

statements required by § 93.405, that the 

conditions of paragraph (d)(2) of this 

section, as applicable, have been met. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

■ 10. Section § 93.420 is revised to read 

as follows: 

§ 93.420 Ruminants from Canada for 

immediate slaughter other than sheep and 

goats. 

(a) General requirements. The 

requirements for the importation of 

sheep and goats from Canada for 

immediate slaughter are contained in 

§ 93.419. There are no BSE-related 

restrictions on the importation of 

cervids or camelids from Canada. All 

other ruminants imported from Canada 

for immediate slaughter, in addition to 

meeting all other applicable 

requirements of this part, may be 

imported only under the following 

conditions: 

(1) The ruminants must be imported 

only through a port of entry listed in 

§ 93.403(b) or as provided for in 

§ 93.403(f) and be inspected at the port 

of entry and otherwise handled in 

accordance with § 93.408. 

(2) The ruminants must be moved 

directly from the port of entry to a 

recognized slaughtering establishment 

in conveyances that are sealed with 

seals of the U.S. Government at the port 

of entry. The seals may be broken only 

at the recognized slaughtering 

establishment by an authorized USDA 

representative. 

(3) The ruminants must be 

accompanied from the port of entry to 

the recognized slaughtering 

establishment by APHIS Form VS 17– 

33, which must include the location of 

the recognized slaughtering 

establishment. 

(b) Bovines. In addition to meeting the 

requirements of paragraph (a) of this 

section, bovines may be imported from 

Canada for immediate slaughter only 

under the following conditions: 

(1) The bovines must have been born 

after March 1, 1999, the date determined 

by APHIS to be the date of effective 

enforcement of a ruminant-to-ruminant 

feed ban in Canada; 

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(2) Before the animal’s arrival at the 

port of entry into the United States, each 

bovine imported into the United States 

from Canada must be officially 

identified with unique individual 

identification that is traceable to the 

premises of origin of the animal. No 

person may alter, deface, remove, or 

otherwise tamper with the official 

identification while the animal is in the 

United States or moving into or through 

the United States, except that the 

identification may be removed at 

slaughter; and 

(3) The bovines must be accompanied 

by a certificate issued in accordance 

with § 93.405 that states, in addition to 

the statements required by § 93.405, that 

the conditions of paragraphs (b)(1) and 

(b)(2) of this section have been met. 

(Approved by the Office of Management and 

Budget under control numbers 0579–0234 

and 0579–0393) 

■ 11. In § 93.423, paragraph (e) is added 

to read as follows: 

§ 93.423 Ruminants from Central America 

and the West Indies. 

* * * * * 

(e) In addition to meeting all other 

applicable requirements of this part, 

bovines from Central America and the 

West Indies may be imported only in 

accordance with § 93.436. 

* * * * * 

■ 12. Section 93.427 is amended as 

follows: 

■ a. By revising the section heading; 

■ b. By adding paragraph (e); and 

■ c. By adding an OMB citation at the 

end of the section. 

The revision and additions read as 

follows: 

§ 93.427 Cattle and other bovines from 

Mexico. 

* * * * * 

(e) BSE. In addition to meeting the 

requirements of paragraphs (a) through 

(d) of this section and all other 

applicable requirements of this part, 

bovines may be imported from Mexico 

only under the following conditions: 

(1) The bovines were born after 

November 30, 2007, the date determined 

by APHIS to be the date of effective 

enforcement of a ruminant-to-ruminant 

feed ban in Mexico. 

(2) The bovines were officially 

identified prior to arriving at the port of 

entry in the United States with unique 

individual identification that is 

traceable to each bovine’s premises of 

origin. No person may alter, deface, 

remove, or otherwise tamper with the 

official identification while the animal 

is in the United States or moving into 

or through the United States, except that 

the identification may be removed at 

slaughter. 

(3) The bovines, if sexually intact, are 

permanently and humanely identified 

using one of the following additional 

methods: 

(i) An ‘‘MX’’ mark properly applied 

with a freeze brand, hot iron, or other 

method, and easily visible on the live 

animal and on the carcass before 

skinning. Such a mark must be not less 

than 2 inches nor more than 3 inches 

high, and must be applied to each 

animal’s right hip, high on the tail-head 

(over the junction of the sacral and first 

coccygeal vertebrae); or 

(ii) A tattoo with the letters ‘‘MX’’ 

applied to the inside of one ear of the 

animal; or 

(iii) Other means of permanent 

identification upon request if deemed 

adequate by the Administrator to 

humanely identify the animal in a 

distinct and legible way as having been 

imported from Mexico. 

(4) The bovines are accompanied by a 

certificate issued in accordance with 

§ 93.405 that states, in addition to the 

statements required by § 93.405, that the 

conditions of paragraphs (e)(1) through 

(e)(3) of this section have been met. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

■ 13. In § 93.432, the section heading is 

revised and paragraph (e) is added to 

read as follows: 

§ 93.432 Cattle and other bovines from the 

Republic of Ireland. 

* * * * * 

(e) In addition to meeting all other 

applicable requirements of this part, 

bovines from the Republic of Ireland 

may be imported only in accordance 

with § 93.436. 

■ 14. Section § 93.436 is revised to read 

as follows: 

§ 93.436 Bovines from regions of 

negligible risk, controlled risk, and 

undetermined risk for BSE. 

The importation of bovines is 

prohibited, unless the conditions of this 

section and any other applicable 

conditions of this part are met. Once the 

bovines are imported, if they do not 

meet the conditions of this section, they 

must be disposed of as the 

Administrator may direct. 

(a) Bovines from a region of negligible 

risk for BSE in which there has been no 

indigenous case of BSE. Bovines from a 

region of negligible risk for BSE, as 

defined in § 92.1 of this subchapter, in 

which there has been no indigenous 

case of BSE, may be imported only if the 

bovines are accompanied by an original 

certificate issued by a full-time salaried 

veterinary officer of the national 

government of the exporting region, or 

issued by a veterinarian designated or 

accredited by the national government 

of the exporting region and endorsed by 

a full-time salaried veterinary officer of 

the national government of the 

exporting region, representing that the 

veterinarian issuing the certificate was 

authorized to do so, and the certificate 

attests that the exporting region of the 

bovines is classified by APHIS as a 

negligible-risk region for BSE in which 

there has been no indigenous case of 

BSE. 

(b) Bovines from a region of negligible 

risk for BSE in which there has been an 

indigenous case of BSE and bovines 

from a region of controlled risk for BSE. 

Bovines from a region of negligible risk 

for BSE, as defined in § 92.1 of this 

subchapter, in which there has been an 

indigenous case of BSE, and bovines 

from a region of controlled risk for BSE, 

as defined in § 92.1 of this subchapter, 

may be imported only under the 

following conditions: 

(1) Prior to importation into the 

United States, each bovine is officially 

identified with unique individual 

identification that is traceable to the 

premises of origin of the animal. No 

person may alter, deface, remove, or 

otherwise tamper with the official 

identification while the animal is in the 

United States or moving into or through 

the United States, except that the 

identification may be removed at 

slaughter. 

(2) The bovines are permanently and 

humanely identified before arrival at the 

port of entry with a distinct and legible 

mark identifying the exporting country. 

Acceptable means of permanent 

identification include the following: 

(i) A mark properly applied with a 

freeze brand, hot iron, or other method, 

and easily visible on the live animal and 

on the carcass before skinning. Such a 

mark must be not less than 2 inches nor 

more than 3 inches high, and must be 

applied to each animal’s right hip, high 

on the tail-head (over the junction of the 

sacral and first coccygeal vertebrae); 

(ii) A tattoo with letters identifying 

the exporting country must be applied 

to the inside of one ear of the animal; 

or 

(iii) Other means of permanent 

identification upon request if deemed 

adequate by the Administrator to 

humanely identify the animal in a 

distinct and legible way as having been 

imported from a region of negligible risk 

for BSE in which there has been an 

indigenous case of BSE or from a region 

of controlled risk for BSE. 

(3) The bovines were born after the 

date from which the ban on the feeding 

of ruminants meat-and-bone meal or 

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greaves derived from ruminants has 

been effectively enforced. 

(4) The bovines are accompanied by 

an original certificate issued by a fulltime salaried veterinary officer of the 

national government of the exporting 

region, or issued by a veterinarian 

designated or accredited by the national 

government of the exporting region and 

endorsed by a full-time salaried 

veterinary officer of the national 

government of the exporting region, 

representing that the veterinarian 

issuing the certificate was authorized to 

do so, and the certificate attests to the 

BSE risk classification of the exporting 

region and that the conditions of 

paragraphs (b)(1) through (b)(3) of this 

section have been met. 

(5) If there has been an indigenous 

case of BSE in the exporting region, the 

following restrictions apply: 

(i) Bovines that, during their first year 

of life, were reared with a bovine 

determined to be infected with BSE 

during its first year of life, and that an 

investigation showed consumed the 

same potentially contaminated feed as 

the infected animal during that period 

are not eligible for importation into the 

United States; and 

(ii) If the investigation was unable to 

determine whether the feed source that 

was used to feed the bovine known to 

be infected was also used to feed other 

bovines in the herd of the infected 

animal, all bovines born in the same 

herd as a BSE-infected bovine either 

within 12 months before or 12 months 

after the birth of the infected animal are 

not eligible for importation into the 

United States. 

(c) Bovines from a region of 

undetermined risk for BSE. Importation 

of bovines from a region of 

undetermined risk for BSE, as defined 

in § 92.1 of this subchapter, is 

prohibited; Except that: The 

Administrator may allow such imports 

on a case-by-case basis if the live 

bovines are imported for specific uses, 

including, but not limited to, show or 

exhibition, and under conditions 

determined by the Administrator to be 

adequate to prevent the spread of BSE. 

(Approved by the Office of Management and 

Budget under control number 0579–0234) 

PART 94—RINDERPEST, FOOT-ANDMOUTH DISEASE, NEWCASTLE 

DISEASE, HIGHLY PATHOGENIC 

AVIAN INFLUENZA, AFRICAN SWINE 

FEVER, CLASSICAL SWINE FEVER, 

SWINE VESICULAR DISEASE, AND 

BOVINE SPONGIFORM 

ENCEPHALOPATHY: PROHIBITED 

AND RESTRICTED IMPORTATIONS 

■ 15. The authority citation for part 94 

continues to read as follows: 

Authority: 7 U.S.C. 450, 7701–7772, 7781– 

7786, and 8301–8317; 21 U.S.C. 136 and 

136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 

371.4. 

■ 16. Section 94.0 is amended by 

removing the definitions of cervid and 

specified risk materials (SRMs) and 

adding definitions of exporting region, 

mechanically separated meat, processed 

animal protein, specified risk materials 

(SRMs) from regions of controlled risk 

for BSE, and specified risk materials 

(SRMs) from regions of undetermined 

risk for BSE in alphabetical order to read 

as follows: 

§ 94.0 Definitions. 

* * * * * 

Exporting region. A region from 

which shipments are sent to the United 

States. 

* * * * * 

Mechanically separated meat. A 

finely comminuted product resulting 

from the mechanical separation and 

removal of most of the bone from 

attached skeletal muscle of bovine 

carcasses that meets the FSIS 

specifications contained in 9 CFR 319.5. 

* * * * * 

Processed animal protein. Meat meal, 

bone meal, meat-and-bone meal, blood 

meal, dried plasma and other blood 

products, hydrolyzed protein, hoof 

meal, horn meal, poultry meal, feather 

meal, fish meal, and any other similar 

products. 

* * * * * 

Specified risk materials (SRMs) from 

regions of controlled risk for BSE. Those 

bovine parts considered to be at 

particular risk of containing the BSE 

agent in infected animals, as listed in 

the FSIS regulations at 9 CFR 310.22(a). 

Specified risk materials (SRMs) from 

regions of undetermined risk for BSE. 

Those bovine parts considered to be at 

particular risk of containing the BSE 

agent in infected animals, as listed in 

the FSIS regulations at 9 CFR 310.22(a), 

except that the following bovine parts 

from regions of undetermined risk for 

BSE are considered SRMs if they are 

derived from bovines over 12 months of 

age: Brain, skull, eyes, trigeminal 

ganglia, spinal cord, vertebral column 

(excluding the vertebrae of the tail, the 

transverse processes of the thoracic and 

lumbar vertebrae, and the wings of the 

sacrum), and the dorsal root ganglia. 

* * * * * 

§ 94.1 [Amended] 

■ 17. In § 94.1, paragraphs (b)(4) and (d) 

are amended by removing the citation 

‘‘§ 94.22’’ both times it appears and 

adding the citation ‘‘§ 94.29’’ in their 

place. 

§ 94.9 [Amended] 

■ 18. In § 94.9, paragraph (c) is amended 

by removing the citation ‘‘§ 94.24’’ and 

adding the citation ‘‘§ 94.31’’ in its 

place. 

§ 94.10 [Amended] 

■ 19. In § 94.10, paragraph (c) is 

amended by removing the citation 

‘‘§ 94.24’’ and adding the citation 

‘‘§ 94.31’’ in its place. 

■ 20. Section 94.18 is revised to read as 

follows: 

§ 94.18 Bovine spongiform 

encephalopathy; importation of edible 

products derived from bovines. 

(a) The importation of meat, meat 

products, and other edible products 

derived from bovines is prohibited with 

regard to BSE, except as provided in this 

section and in §§ 94.19, 94.20, 94.21, 

94.22, 94.23, and 94.27. 

(b) The following commodities 

derived from bovines may be imported 

into the United States without 

restriction regarding BSE, provided that 

all other applicable requirements of this 

part are met: 

(1) Milk and milk products; 

(2) Boneless skeletal muscle meat 

(excluding mechanically separated 

meat) that: 

(i) Is derived from bovines that were 

not, prior to slaughter, subjected to a 

pithing process or to stunning with a 

device injecting compressed air or gas 

into the cranial cavity, and that passed 

ante-mortem and post-mortem 

inspection; 

(ii) Has been prepared in a manner to 

prevent contamination with SRMs; and 

(iii) Is accompanied to the United 

States by an original certificate stating 

that the conditions of paragraphs 

(b)(2)(i) and (b)(2)(ii) of this section have 

been met. The certificate must be issued 

and signed by a full-time salaried 

veterinary officer of the national 

government of the exporting region or 

signed by a person authorized to issue 

such certificates by the veterinary 

services of the national government of 

the exporting region. 

(Approved by the Office of Management and 

Budget under control number 0579–0015) 

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■ 21. Section 94.19 is revised to read as 

follows: 

§ 94.19 Importation of meat, meat 

byproducts, and meat food products 

derived from bovines from regions of 

negligible risk for BSE. 

Meat, meat byproducts, and meat food 

products, as defined by FSIS in 9 CFR 

301.2–except that those terms as applied 

to bison shall have a meaning 

comparable to those provided in 9 CFR 

301.2 with regard to cattle, and other 

than boneless skeletal meat that meets 

the conditions of § 94.18(b)(2)—may be 

imported from a region of negligible risk 

for BSE, as defined in § 92.1 of this 

subchapter, if the following conditions 

and all other applicable requirements of 

this part are met: 

(a) The commodities were exported 

from a region of negligible risk for BSE. 

(b) If BSE has been diagnosed in one 

or more indigenous bovines in the 

region of negligible risk, the 

commodities were derived from bovines 

subject to a ban on the feeding to 

ruminants of meat-and-bone meal or 

greaves derived from ruminants. 

(c) The commodities were derived 

from bovines that passed ante-mortem 

and post-mortem inspections. 

(d) The commodities are accompanied 

by an original certificate stating that the 

exporting region is classified by APHIS 

as a region of negligible risk for BSE and 

that the conditions of paragraphs (a) 

through (c) of this section, as applicable, 

have been met. The certificate must be 

issued and signed by a full-time salaried 

veterinary officer of the national 

government of the exporting region, or 

signed by a person authorized to issue 

such certificates by the veterinary 

services of the national government of 

the exporting region. 

Note: To be eligible to export meat, meat 

byproducts, and meat food products under 

the conditions of this section for human 

consumption, a region must also be one that 

has demonstrated to FSIS in accordance with 

9 CFR 310.22 that its BSE risk status can 

reasonably be expected to provide the same 

level of protection from human exposure to 

the BSE agent as does prohibiting specified 

risk materials for use as human food in the 

United States. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

■ 22. Section 94.20 is revised to read as 

follows: 

§ 94.20 Importation of meat, meat 

byproducts, and meat food products 

derived from bovines from regions of 

controlled risk for BSE. 

Meat, meat byproducts, and meat food 

products, as defined by FSIS in 9 CFR 

301.2—except that those terms as 

applied to bison shall have a meaning 

comparable to those provided in 9 CFR 

301.2 with regard to cattle, and other 

than boneless skeletal meat that meets 

the conditions of § 94.18(b)(2)—may be 

imported from a region of controlled 

risk for BSE, as defined in § 92.1 of this 

subchapter, if the following conditions 

and all other applicable requirements of 

this part are met: 

(a) The commodities were exported 

from a region of controlled risk for BSE. 

(b) The commodities were derived 

from bovines that passed ante-mortem 

and post-mortem inspections. 

(c) The commodities were derived 

from bovines that were not subjected to 

a stunning process, prior to slaughter, 

with a device injecting compressed air 

or gas into the cranial cavity, or to a 

pithing process. 

(d) The commodities were produced 

and handled in a manner that ensured 

that such commodities do not contain 

and are not contaminated with either of 

the following: 

(1) SRMs from regions of controlled 

risk for BSE; or 

(2) Mechanically separated meat from 

the skull and vertebral column from 

bovines 30 months of age or older. 

(e) The commodities are accompanied 

by an original certificate stating that the 

exporting region is classified by APHIS 

as a region of controlled risk for BSE, 

and that the conditions of this section 

have been met. The certificate must be 

issued and signed by a full-time salaried 

veterinary officer of the national 

government of the exporting region, or 

signed by a person authorized to issue 

such certificates by the veterinary 

services of the national government of 

the exporting region. 

(Approved by the Office of Management and 

Budget under control numbers 0579–0015 

and 0579–0393) 

■ 23. Section 94.21 is added to read as 

follows: 

§ 94.21 Importation of meat, meat 

byproducts, and meat food products 

derived from bovines from regions of 

undetermined risk for BSE. 

Meat, meat byproducts, and meat food 

products, as defined by FSIS in 9 CFR 

301.2–except that those terms as applied 

to bison shall have a meaning 

comparable to those provided in 9 CFR 

301.2 with regard to cattle, and other 

than boneless skeletal meat that meets 

the conditions of § 94.18(b)(2)—may be 

imported from regions of undetermined 

risk for BSE, as defined in § 92.1 of this 

subchapter, if the following conditions 

and all other applicable requirements of 

this part are met: 

(a) The commodities were derived 

from bovines that have never been fed 

meat-and-bone meal or greaves derived 

from ruminants. 

(b) The commodities were derived 

from bovines that passed ante-mortem 

and post-mortem inspections. 

(c) The commodities were derived 

from bovines that were not subjected to 

a stunning process, prior to slaughter, 

with a device injecting compressed air 

or gas into the cranial cavity, or to a 

pithing process. 

(d) The commodities were produced 

and handled in a manner that ensured 

that such commodities do not contain 

and are not contaminated with any of 

the following: 

(1) SRMs from regions of 

undetermined risk for BSE; or 

(2) Mechanically separated meat from 

the skull and vertebral column from 

bovines over 12 months of age. 

(e) The commodities are accompanied 

by an original certificate stating that the 

exporting region is a region of 

undetermined risk for BSE and that the 

conditions of this section have been 

met. The certificate must be issued and 

signed by a full-time salaried veterinary 

officer of the national government of the 

exporting region, or signed by a person 

authorized to issue such certificates by 

the veterinary services of the national 

government of the exporting region. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

§ 94.27 [Removed] 

■ 24. Section 94.27 is removed. 

§§ 94.22 through 94.26 [Redesignated 

§§ 94.29 through 94.33] 

■ 25. Sections 94.22 through 94.26 are 

redesignated as §§ 94.29 through 94.33, 

respectively. 

■ 26. New §§ 94.22 through 94.27 are 

added to read as follows: 

Sec. 

* * * * * 

94.22 Meat or dressed carcasses of hunterharvested bovines. 

94.23 Importation of gelatin derived from 

bovines. 

94.24 Restrictions on importation of meat 

and edible products from ovines and 

caprines due to bovine spongiform 

encephalopathy. 

94.25 Restrictions on the importation from 

Canada of meat and edible products from 

ovines and caprines other than gelatin. 

94.26 Gelatin derived from horses or swine 

or from ovines or caprines that have not 

been in a region restricted because of 

BSE. 

94.27 Transit shipment of articles. 

* * * * * 

§ 94.22 Meat or dressed carcasses of 

hunter-harvested bovines. 

The meat or dressed carcass 

(eviscerated and the head is removed) is 

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derived from a wild bovine that has 

been legally harvested in the wild, as 

verified by proof such as a hunting 

license, tag, or the equivalent that the 

hunter must show to the authorized 

inspector. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

§ 94.23 Importation of gelatin derived from 

bovines. 

(a) The importation of gelatin derived 

from bovines is prohibited because of 

BSE, unless: 

(1) The gelatin meets the requirements 

of either paragraph (b), (c), or (d), as 

well as the requirements of paragraph 

(e) of this section and all other 

applicable requirements of this part; or 

(2) The gelatin is authorized 

importation under paragraph (f) of this 

section and meets all other applicable 

requirements of this part. 

(b) The gelatin is derived from hides 

and skins, provided the gelatin has not 

been commingled with materials 

ineligible for entry into the United 

States. 

(c) The gelatin is derived from the 

bones of bovines and originates in a 

region of negligible risk for BSE. 

(d) The gelatin is derived from the 

bones of bovines, originates in a region 

of controlled risk or undetermined risk 

for BSE, and meets the requirements of 

paragraphs (d)(1) through (d)(4) of this 

section: 

(1) The bones from which the gelatin 

was derived were derived from bovines 

that passed ante-mortem and postmortem inspection. 

(2) The bones from which the gelatin 

was derived did not include the skulls 

of bovines or the vertebral column of 

bovines 30 months of age or older. 

(3) The bones were subjected to a 

process that includes all of the 

following steps, or to a process at least 

as effective in reducing BSE infectivity: 

(i) Degreasing; 

(ii) Acid demineralization; 

(iii) Acid or alkaline treatment; 

(iv) Filtration; and 

(v) Sterilization at 138 °C (280.4 °F) or 

greater for a minimum of 4 seconds; and 

(4) The gelatin has not been 

commingled with materials ineligible 

for entry into the United States. 

(e) The gelatin is accompanied to the 

United States by an original certificate 

signed by a full-time salaried veterinary 

officer of the national government of the 

exporting region, or issued by a 

veterinarian designated by the national 

government of the exporting region and 

endorsed by a full-time salaried 

veterinary officer of the national 

government of the exporting region, 

representing that the veterinarian 

issuing the certificate was authorized to 

do so. The certificate must state that the 

requirements of paragraph (b), (c), or (d) 

of this section, as applicable, have been 

met and, for gelatin other than that 

described in paragraph (b) of this 

section, must indicate the BSE risk 

classification of the exporting region. 

(f) The Administrator determines that 

the gelatin will not come into contact 

with ruminants in the United States and 

can be imported under conditions that 

will prevent the introduction of BSE 

into the United States, and the person 

importing the gelatin has obtained a 

United States Veterinary Permit for 

Importation and Transportation of 

Controlled Materials and Organisms and 

Vectors. To apply for a permit, file a 

permit application on VS Form 16–3 

(available from APHIS, Veterinary 

Services, National Center for Import and 

Export, 4700 River Road Unit 38, 

Riverdale, MD 20737–1231, or 

electronically at http://

www.aphis.usda.gov/animal_health/

permits/). The application for such a 

permit must state the intended use of 

the gelatin and name and address of the 

consignee in the United States. 

§ 94.24 Restrictions on importation of 

meat and edible products from ovines and 

caprines due to bovine spongiform 

encephalopathy. 

(a) Except as provided in paragraph 

(b) of this section and in § 94.25, the 

importation of meat, meat products, and 

edible products other than meat 

(excluding milk and milk products) 

from ovines and caprines that have been 

in any of the following regions is 

prohibited: Albania, Andorra, Austria, 

Belgium, Bosnia-Herzegovina, Bulgaria, 

Canada, Croatia, the Czech Republic, 

Denmark, the Federal Republic of 

Yugoslavia, Finland, France, Germany, 

Greece, Hungary, the Republic of 

Ireland, Israel, Italy, Japan, 

Liechtenstein, Luxembourg, the Former 

Yugoslav Republic of Macedonia, 

Monaco, Norway, Oman, the 

Netherlands, Poland, Portugal, Romania, 

San Marino, Slovakia, Slovenia, Spain, 

Sweden, Switzerland, and the United 

Kingdom. 

(b) The importation of gelatin derived 

from ovines or caprines that have been 

in any region listed in paragraph (a) of 

this section is prohibited unless the 

following conditions have been met: 

(1) The gelatin is imported for use in 

human food, human pharmaceutical 

products, photography, or some other 

use that will not result in the gelatin 

coming in contact with ruminants in the 

United States. 

(2) The person importing the gelatin 

obtains a United States Veterinary 

Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors by filing a 

permit application on VS Form 16–3. To 

apply for a permit, file a permit 

application on VS Form 16–3 (available 

from APHIS, Veterinary Services, 

National Center for Import and Export, 

4700 River Road Unit 38, Riverdale, MD 

20737–1231, or electronically at http:// 

www.aphis.usda.gov/animal_health/

permits/). The application for such a 

permit must state the intended use of 

the gelatin and name and address of the 

consignee in the United States. 

§ 94.25 Restrictions on the importation 

from Canada of meat and edible products 

from ovines and caprines other than 

gelatin. 

The commodities listed in paragraphs 

(a) and (b) of this section may be 

imported from Canada if the conditions 

of this section are met. 

(a) Meat, carcasses, meat byproducts, 

and meat food products from ovines or 

caprines. (1) The meat, carcass, meat 

byproduct, or meat food product, as 

defined by FSIS in 9 CFR 301.2, is 

derived from ovines or caprines that are 

from a flock or herd subject to a 

ruminant feed ban equivalent to the 

requirements established by the U.S. 

Food and Drug Administration at 21 

CFR 589.2000, and the ovines or 

caprines: 

(i) Were less than 12 months of age 

when slaughtered; 

(ii) Were slaughtered at a facility that 

either slaughters only ovines or caprines 

less than 12 months of age or complies 

with a segregation process approved by 

the national veterinary authority of the 

region of origin and the Administrator 

as adequate to prevent contamination or 

commingling of the meat with products 

not eligible for importation into the 

United States; 

(iii) Did not test positive for and were 

not suspect for a transmissible 

spongiform encephalopathy; 

(iv) Never resided in a flock or herd 

that has been diagnosed with BSE; and 

(v) Were not subject to any movement 

restrictions within Canada as a result of 

exposure to a transmissible spongiform 

encephalopathy. 

(2) The commodities are accompanied 

by an original certificate of such 

compliance issued by a full-time 

salaried veterinary officer of Canada, or 

issued by a veterinarian designated by 

the Canadian government and endorsed 

by a full-time salaried veterinary officer 

of the Government of Canada, 

representing that the veterinarian 

issuing the certificate was authorized to 

do so; and if all other applicable 

requirements of this part are met. 

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(b) Meat or dressed carcasses of 

hunter-harvested ovines or caprines. (1) 

The meat or dressed carcass (eviscerated 

and the head is removed) is derived 

from a wild ovine or caprine that has 

been legally harvested in the wild, as 

verified by proof such as a hunting 

license, tag, or the equivalent that the 

hunter must show to the United States 

Customs and Border Protection official; 

and 

(2) The animal from which the meat 

is derived was harvested within a 

jurisdiction specified by the 

Administrator for which the game and 

wildlife service of the jurisdiction has 

informed the Administrator either that 

the jurisdiction conducts no type of 

game feeding program, or has complied 

with, and continues to comply with, a 

ruminant feed ban equivalent to the 

requirements established by the U.S. 

Food and Drug Administration at 21 

CFR 589.2000. 

(c) Ports. All products to be brought 

into the United States under this section 

must, if arriving at a land border port, 

arrive at one of the following ports: 

Eastport, ID; Houlton, ME; Detroit 

(Ambassador Bridge), Port Huron, and 

Sault St. Marie, MI; International Falls, 

MN; Sweetgrass, MT; Alexandria Bay, 

Buffalo (Lewiston Bridge and Peace 

Bridge), and Champlain, NY; Pembina 

and Portal, ND; Derby Line and 

Highgate Springs, VT; and Blaine 

(Pacific Highway and Cargo Ops), 

Lynden, Oroville, and Sumas (Cargo), 

WA. 

§ 94.26 Gelatin derived from horses or 

swine or from ovines or caprines that have 

not been in a region restricted because of 

BSE. 

Gelatin derived from horses or swine, 

or from ovines or caprines that have not 

been in any region listed in § 94.24(a) 

must be accompanied at the time of 

importation into the United States by an 

official certificate issued by a 

veterinarian employed by the national 

government of the region of origin. The 

official certificate must state the species 

of animal from which the gelatin is 

derived and, if the gelatin is derived 

from ovines or caprines, certify that the 

gelatin is not derived from ovines or 

caprines that have been in any region 

listed in § 94.24(a). 

§ 94.27 Transit shipment of articles. 

Meat, meat products, and other edible 

products derived from bovines, ovines, 

or caprines that are otherwise 

prohibited importation into the United 

States in accordance with § 94.18 

through § 94.26 may transit air and 

ocean ports in the United States for 

immediate export if the conditions of 

paragraphs (a) through (c) this section 

are met. Meat, meat products, and other 

edible products derived from bovines, 

ovines, or caprines are eligible to transit 

the United States by overland 

transportation if the requirements of 

paragraphs (a) through (d) of this section 

are met: 

(a) The articles must be sealed in 

leakproof containers bearing serial 

numbers during transit. Each container 

must remain sealed during the entire 

time that it is in the United States. 

(b) The person moving the articles 

must notify, in writing, the inspector at 

both the place in the United States 

where the articles will arrive and the 

port of export before such transit. The 

notification must include the: 

(1) Times and dates of arrival in the 

United States; 

(2) Times and dates of exportation 

from the United States; 

(3) Mode of transportation; and 

(4) Serial numbers of the sealed 

containers. 

(c) The articles must transit the 

United States in Customs bond. 

(d) The commodities must be eligible 

to enter the United States in accordance 

with the provisions of this part and 

must be accompanied by the 

certification required by that section. 

Additionally, the following conditions 

must be met: 

(1) The shipment must be exported 

from the United States within 7 days of 

its entry; and 

(2) The commodities may not be 

transloaded while in the United States, 

except for direct transloading under the 

supervision of an authorized inspector, 

who must break the seals of the national 

government of the region of origin on 

the means of conveyance that carried 

the commodities into the United States 

and seal the means of conveyance that 

will carry the commodities out of the 

United States with seals of the U.S. 

Government. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

§ 94.28 [Amended] 

■ 27. In § 94.28, paragraph (c) is 

amended by removing the citation 

‘‘§ 94.28(b)(5)’’ and adding ‘‘paragraph 

(b)(5) of this section’’ in its place. 

PART 95—SANITARY CONTROL OF 

ANIMAL BYPRODUCTS (EXCEPT 

CASINGS), AND HAY AND STRAW, 

OFFERED FOR ENTRY INTO THE 

UNITED STATES 

■ 28. The authority citation for part 95 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 21 U.S.C. 

136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 

2.80, and 371.4. 

■ 29. Section 95.1 is amended by 

removing the definition of specified risk 

materials (SRMs), by revising the 

definition of offal, and by adding 

definitions of exporting region, specified 

risk materials (SRMs) from regions of 

controlled risk for BSE, specified risk 

materials (SRMs) from regions of 

undetermined risk for BSE, and tallow 

derivative in alphabetical order to read 

as follows: 

§ 95.1 Definitions. 

* * * * * 

Exporting region. A region from 

which shipments are sent to the United 

States. 

* * * * * 

Offal. The inedible parts of a 

butchered animal. 

* * * * * 

Specified risk materials (SRMs) from 

regions of controlled risk for BSE. Those 

bovine parts considered to be at 

particular risk of containing the BSE 

agent in infected animals, as listed in 

the FSIS regulations at 9 CFR 310.22(a). 

Specified risk materials (SRMs) from 

regions of undetermined risk for BSE. 

Those bovine parts considered to be at 

particular risk of containing the BSE 

agent in infected animals, as listed in 

the FSIS regulations at 9 CFR 310.22(a), 

except that the following bovine parts 

from regions of undetermined risk for 

BSE are considered SRMs if they are 

derived from bovines over 12 months of 

age: Brain, skull, eyes, trigeminal 

ganglia, spinal cord, vertebral column 

(excluding the vertebrae of the tail, the 

transverse processes of the thoracic and 

lumbar vertebrae, and the wings of the 

sacrum), and the dorsal root ganglia. 

* * * * * 

Tallow derivative. Any chemical 

obtained through initial hydrolysis, 

saponification, or transesterification of 

tallow; chemical conversion of material 

obtained by hydrolysis, saponification, 

or transesterification may be applied to 

obtain the desired product. 

* * * * * 

■ 30. Section 95.4 is revised to read as 

follows: 

§ 95.4 Restrictions on the importation of 

processed animal protein, offal, tankage, 

fat, glands, certain tallow other than tallow 

derivatives, and serum due to bovine 

spongiform encephalopathy. 

(a) Except as provided in paragraphs 

(c), (d), (e), (f), or (g) of this section or 

in § 95.15, any of the materials listed in 

paragraph (b) of this section derived 

from animals, or products containing 

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such materials, are prohibited 

importation into the United States if 

paragraph (a)(1), (a)(2), or (a)(3) of this 

section applies: 

(1) The animals have been in any 

region listed in paragraph (a)(4) of this 

section; 

(2) The materials have been stored, 

rendered, or otherwise processed in a 

region listed in paragraph (a)(4) of this 

section; or 

(3) The materials have otherwise been 

associated with a facility in a region 

listed in paragraph (a)(4) of this section. 

(4) Albania, Andorra, Austria, 

Belgium, Bosnia-Herzegovina, Bulgaria, 

Canada, Croatia, the Czech Republic, 

Denmark, the Federal Republic of 

Yugoslavia, Finland, France, Germany, 

Greece, Hungary, the Republic of 

Ireland, Israel, Italy, Japan, 

Liechtenstein, Luxembourg, the Former 

Yugoslav Republic of Macedonia, 

Monaco, Norway, Oman, the 

Netherlands, Poland, Portugal, Romania, 

San Marino, Slovakia, Slovenia, Spain, 

Sweden, Switzerland, and the United 

Kingdom. 

(b) Restricted materials: (1) Processed 

animal protein, tankage, offal, and 

tallow other than tallow derivatives, 

unless in the opinion of the 

Administrator, the tallow cannot be 

used in feed; 

(2) Glands, unprocessed fat tissue, 

and blood and blood products; 

(3) Processed fats and oils, and 

derivatives of processed animal protein, 

tankage, and offal; or 

(4) Derivatives of glands and blood 

and blood products. 

(c) The import prohibition in 

paragraph (a) of this section does not 

apply if the following conditions are 

met prior to importation: 

(1) The material is derived from one 

of the following: 

(i) A nonruminant species and the 

material is not ineligible for importation 

under § 95.13 or § 95.14; 

(ii) Cervids or camelids; 

(iii) Bovines, and the material is not 

ineligible for importation under the 

conditions of § 95.5, § 95.6, § 95.7, 

§ 95.8, § 95.9, § 95.10, or § 95.12; or 

(iv) Ovines or caprines that have 

never been in any region listed in 

paragraph (a)(4) of this section. 

(2) In any region other than Canada 

that is listed in paragraph (a)(4) of this 

section, all steps of processing and 

storing the material are carried out in a 

facility that has not been used for the 

processing and storage of materials 

derived from ovines or caprines that 

have been in any region that is listed in 

paragraph (a)(4) of this section. 

(3) In Canada, all steps of processing 

and storing the material are carried out 

in a facility that has not been used for 

the processing and storage of materials 

derived from ovines and caprines that 

have been in any region other than 

Canada that is listed in paragraph (a)(4) 

of this section. 

(4) The facility demonstrates to 

APHIS that the materials intended for 

exportation to the United States were 

transported to and from the facility in a 

manner that would prevent crosscontamination by or commingling with 

prohibited materials. 

(5) If the facility processes or handles 

any material derived from mammals, 

inspection of the facility for compliance 

with the provisions of this section is 

conducted at least annually by a 

representative of the government agency 

responsible for animal health in the 

region, unless the region chooses to 

have such inspection conducted by 

APHIS. If APHIS conducts the 

inspections required by this section, the 

facility has entered into a cooperative 

service agreement executed by the 

operator of the facility and APHIS. In 

accordance with the cooperative service 

agreement, the facility must be current 

in paying all costs for a veterinarian of 

APHIS to inspect the facility (it is 

anticipated that such inspections will 

occur approximately once per year), 

including travel, salary, subsistence, 

administrative overhead, and other 

incidental expenses (including excess 

baggage provisions up to 150 pounds). 

In addition, the facility must have on 

deposit with APHIS an unobligated 

amount equal to the cost for APHIS 

personnel to conduct one inspection. As 

funds from that amount are obligated, a 

bill for costs incurred based on official 

accounting records will be issued to 

restore the deposit to the original level, 

revised as necessary to allow for 

inflation or other changes in estimated 

costs. To be current, bills must be paid 

within 14 days of receipt. 

(6) The facility allows periodic APHIS 

inspection of its facilities, records, and 

operations. 

(7) Each shipment to the United States 

is accompanied by an original certificate 

signed by a full-time, salaried 

veterinarian of the government agency 

responsible for animal health in the 

exporting region certifying that the 

conditions of paragraphs (c)(1) through 

(c)(5) of this section have been met. 

(8) The person importing the 

shipment has applied for and obtained 

from APHIS a United States Veterinary 

Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors by filing a 

permit application on VS Form 16–3. 

(VS Form 16–3 may be obtained from 

APHIS, Veterinary Services, National 

Center for Import and Export, 4700 

River Road Unit 38, Riverdale, MD 

20737–1231, or electronically at http:// 

www.aphis.usda.gov/animal_health/

permits/.) 

(d) Except as provided in paragraph 

(e) of this section and in § 95.15, serum 

from ovines or caprines that have been 

in any region listed in paragraph (a)(4) 

of this section is prohibited importation 

into the United States, except for 

scientific, educational, or research 

purposes if the Administrator 

determines that the importation can be 

made under conditions that will prevent 

the introduction of BSE into the United 

States. Such serum must be 

accompanied by a permit issued by 

APHIS in accordance with § 104.4 of 

this chapter and must be moved and 

handled as specified on the permit. 

(e) The importation of serum albumin, 

serocolostrum, amniotic liquids or 

extracts, and placental liquids derived 

from ovines or caprines that have been 

in any region listed in paragraph (a)(4) 

of this section, and collagen and 

collagen products that are derived from 

ovines or caprines and that would 

otherwise be prohibited under 

paragraphs (a) and (b) of this section, is 

prohibited unless the following 

conditions have been met: 

(1) The article is imported for use as 

an ingredient in cosmetics; 

(2) The person importing the article 

has obtained a United States Veterinary 

Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors by filing a 

permit application on VS Form 16–3 

(VS Form 16–3 may be obtained from 

APHIS, Veterinary Services, National 

Center for Import and Export, 4700 

River Road Unit 38, Riverdale, MD 

20737–1231, or electronically at http:// 

www.aphis.usda.gov/animal_health/

permits/.); and 

(3) The permit application states the 

intended use of the article and the name 

and address of the consignee in the 

United States. 

(f) Insulin otherwise prohibited under 

paragraphs (a) and (b) of this section 

may be imported if the insulin is for the 

personal medical use of the person 

importing it and if the person importing 

the shipment has applied for and 

obtained from APHIS a United States 

Veterinary Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors. To apply 

for a permit, file a permit application on 

VS Form 16–3 (available from APHIS, 

Veterinary Services, National Center for 

Import and Export, 4700 River Road 

Unit 38, Riverdale, MD 20737–1231, or 

electronically at http://

www.aphis.usda.gov/animal_health/

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permits/). The application for such a 

permit must state the intended use of 

the insulin and the name and address of 

the consignee in the United States. 

Note to paragraph (f): Insulin that is not 

prohibited from importation under this 

paragraph may be prohibited from 

importation under other Federal laws, 

including the Federal Food, Drug, and 

Cosmetic Act, 21 U.S.C. 321 et seq. 

(g) Offal that is otherwise prohibited 

under paragraphs (a) and (b) of this 

section because it is derived from ovines 

or caprines that have been in a region 

listed in paragraph (a)(4) of this section 

may be imported into the United States 

if the offal is derived from ovines or 

caprines from Canada that have not 

been in a region listed in paragraph 

(a)(4) of this section other than Canada, 

and the following conditions are met: 

(1) The offal: 

(i) Is derived from ovines or caprines 

that were less than 12 months of age 

when slaughtered and that are from a 

flock or herd subject to a ruminant feed 

ban equivalent to the requirements 

established by the U.S. Food and Drug 

Administration at 21 CFR 589.2000; 

(ii) Is not derived from ovines or 

caprines that have tested positive for or 

are suspect for a transmissible 

spongiform encephalopathy; 

(iii) Is not derived from animals that 

have resided in a flock or herd that has 

been diagnosed with BSE; and 

(iv) Is derived from ovines or caprines 

whose movement was not restricted in 

the BSE minimal-risk region as a result 

of exposure to a transmissible 

spongiform encephalopathy. 

(2) Each shipment to the United States 

is accompanied by an original certificate 

signed by a full-time salaried veterinary 

officer of the national government of the 

exporting region, or issued by a 

veterinarian designated by the exporting 

region and endorsed by a full-time 

salaried veterinary officer of the 

national government of the exporting 

region, representing that the 

veterinarian issuing the certificate was 

authorized to do so. The certificate must 

state that the requirements of paragraph 

(g)(1) of this section have been met; and 

(3) The shipment, if arriving at a U.S. 

land border port, arrives at a port listed 

in § 94.25(c) of this subchapter. 

(Approved by the Office of Management and 

Budget under control numbers 0579–0015, 

0579–0234, and 0579–0393) 

§§ 95.5 through 95.30 [Redesignated as 

§§ 95.16 through 95.41] 

■ 31. Sections 95.5 through 95.30 are 

redesignated as §§ 95.16 through 95.41, 

respectively. 

■ 32. New §§ 95.5 through 95.15 are 

added to read as follows: 

Sec. 

* * * * * 

95.5 Processed animal protein derived from 

ruminants. 

95.6 Offal derived from bovines. 

95.7 Collagen derived from bovines. 

95.8 Tallow derived from bovines. 

95.9 Derivatives of tallow derived from 

bovines. 

95.10 Dicalcium phosphate derived from 

bovines. 

95.11 Specified risk materials. 

95.12 Blood and blood products derived 

from bovines. 

95.13 Importation from regions of negligible 

risk for BSE of processed animal protein 

derived from animals other than 

ruminants. 

95.14 Importation from regions of 

controlled risk or undetermined risk for 

BSE of processed animal protein derived 

from animals other than ruminants. 

95.15 Transit shipment of articles. 

* * * * * 

§ 95.5 Processed animal protein derived 

from ruminants. 

The importation of ruminant-derived 

processed animal protein, or any 

commodities containing such products, 

is prohibited unless the conditions of 

this section are met: 

(a) The exporting region is a region of 

negligible risk for BSE; and 

(1) The product has not been 

commingled or contaminated with 

ruminant meat-and-bone meal or 

greaves from a region of controlled or 

undetermined risk for BSE; and 

(2) The product must be derived from 

ruminants that were subject to a ban on 

the feeding of ruminants with meat-andbone meal or greaves derived from 

ruminants if it is either: 

(i) Exported from a region of 

negligible risk for BSE in which there 

has been at least one indigenous case of 

BSE; or 

(ii) Derived from ruminants that were 

in a region of negligible risk for BSE in 

which there has been at least one 

indigenous case of BSE. 

(b) The exporting region is a region of 

controlled or undetermined risk, the 

product is ruminant-derived processed 

animal protein other than ruminant 

meat-and-bone meal or greaves, and it 

has been demonstrated that the product 

has not been commingled or 

contaminated with ruminant meat-andbone meal or greaves from a controlled 

or undetermined risk region. 

(c) Each shipment to the United States 

is accompanied by an original certificate 

signed by a full-time salaried veterinary 

officer of the national government of the 

exporting region, or issued by a 

veterinarian designated by the national 

government of the exporting region and 

endorsed by a full-time salaried 

veterinary officer of the national 

government of the exporting region, 

representing that the veterinarian 

issuing the certificate was authorized to 

do so. The certificate must state the 

exporting region and that the 

requirements of this section, as 

applicable, have been met. 

(d) The person importing the 

processed animal protein obtains a 

United States Veterinary Permit for 

Importation and Transportation of 

Controlled Materials and Organisms and 

Vectors by filing a permit application on 

VS Form 16–3. To apply for a permit, 

file a permit application on VS Form 

16–3 (available from APHIS, Veterinary 

Services, National Center for Import and 

Export, 4700 River Road Unit 38, 

Riverdale, MD 20737–1231, or 

electronically at http://

www.aphis.usda.gov/animal_health/

permits/). The application for such a 

permit must state the intended use of 

the processed animal protein and name 

and address of the consignee in the 

United States. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

§ 95.6 Offal derived from bovines. 

Offal derived from bovines is 

prohibited importation into the United 

States unless it meets the requirements 

for the importation of meat, meat 

products, and meat byproducts in either 

§ 94.19, § 94.20, or § 94.21, with the 

exception of the requirements in 

§ 94.19(c), § 94.20(b), and § 94.21(b), 

respectively. The person importing the 

offal must obtain a United States 

Veterinary Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors by filing a 

permit application on VS Form 16–3. To 

apply for a permit, file a permit 

application on VS Form 16–3 (available 

from APHIS, Veterinary Services, 

National Center for Import and Export, 

4700 River Road Unit 38, Riverdale, MD 

20737–1231, or electronically at http:// 

www.aphis.usda.gov/animal_health/

permits/). The application for such a 

permit must state the intended use of 

the offal and name and address of the 

consignee in the United States. 

§ 95.7 Collagen derived from bovines. 

(a) The importation of collagen 

derived from bovines is prohibited 

because of BSE unless: 

(1) The collagen meets the 

requirements of either paragraph (b), (c), 

or (d), as well as the requirements of 

paragraph (e) of this section and all 

other applicable requirements of this 

part; or 

(2) The collagen is authorized 

importation under paragraph (f) of this 

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section and meets all other applicable 

requirements of this part: 

(b) The collagen is derived from hides 

and skins, provided the collagen has not 

been commingled with materials 

ineligible for entry into the United 

States. 

(c) The collagen is derived from the 

bones of bovines that originated from a 

region of negligible risk for BSE. 

(d) The collagen is derived from the 

bones of bovines that originated from a 

region of controlled or undetermined 

risk for BSE and meets the requirements 

of paragraphs (d)(1) through (d)(4) of 

this section: 

(1) The bones from which the collagen 

was derived were derived from bovines 

that passed ante-mortem and postmortem inspection; 

(2) The bones from which the collagen 

was derived did not include the skulls 

of bovines or the vertebral column of 

bovines 30 months of age or older; 

(3) The bones were subjected to a 

process that includes all of the 

following steps, or to a process at least 

as effective in reducing BSE infectivity: 

(i) Degreasing; 

(ii) Acid demineralization; 

(iii) Acid or alkaline treatment; 

(iv) Filtration; and 

(v) Sterilization at 138 °C (280.4 °F) or 

greater for a minimum of 4 seconds; and 

(4) The collagen has not been 

commingled with materials ineligible 

for entry into the United States. 

(e) The collagen is accompanied to the 

United States by an original certificate 

signed by a full-time salaried veterinary 

officer of the national government of the 

exporting region, or issued by a 

veterinarian designated by the national 

government of the exporting region and 

endorsed by a full-time salaried 

veterinary officer of the national 

government of the exporting region, 

representing that the veterinarian 

issuing the certificate was authorized to 

do so. The certificate must state that the 

requirements of paragraph (b), (c), or (d) 

of this section, as applicable, have been 

met and, for collagen other than that 

described in paragraph (b) of this 

section, must indicate the BSE risk 

classification of the exporting region. 

(f) The Administrator determines that 

the collagen will not come into contact 

with ruminants in the United States and 

can be imported under conditions that 

will prevent the introduction of BSE 

into the United States, and the person 

importing the collagen has obtained a 

United States Veterinary Permit for 

Importation and Transportation of 

Controlled Materials and Organisms and 

Vectors. To apply for a permit, file a 

permit application on VS Form 16–3 

(available from APHIS, Veterinary 

Services, National Center for Import and 

Export, 4700 River Road Unit 38, 

Riverdale, MD 20737–1231, or 

electronically at http://

www.aphis.usda.gov/animal_health/

permits/). The application for such a 

permit must state the intended use of 

the collagen and the name and address 

of the consignee in the United States. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

§ 95.8 Tallow derived from bovines. 

(a) The importation of bovine-derived 

tallow is prohibited unless: 

(1) The requirements of either 

paragraph (b), (c), or (d), as well as the 

requirements of paragraph (e) of this 

section are met; or 

(2) The requirements of paragraph (f) 

of this section are met. 

(b) The tallow is composed of a 

maximum level of insoluble impurities 

of 0.15 percent in weight; or 

(c) The tallow originates from a region 

of negligible risk for BSE; or 

(d) The tallow originates from a region 

of controlled risk for BSE, is derived 

from bovines that have passed antemortem and post-mortem inspections, 

and has not been prepared using SRMs 

as defined for regions of controlled risk 

for BSE in § 92.1 of this subchapter. 

(e) The tallow is accompanied to the 

United States by an original certificate 

signed by a full-time salaried veterinary 

officer of the national government of the 

exporting region, or issued by a 

veterinarian designated by the national 

government of the exporting region and 

endorsed by a full-time salaried 

veterinary officer of the national 

government of the exporting region, 

representing that the veterinarian 

issuing the certificate was authorized to 

do so. The certificate must state that the 

requirements of paragraph (b), (c), or (d) 

of this section, as applicable, have been 

met and, for tallow other than that 

described in paragraph (b) of this 

section, must indicate the BSE risk 

classification of the exporting region. 

(f) The Administrator determines that 

the tallow will not come into contact 

with ruminants in the United States and 

can be imported under conditions that 

will prevent the introduction of BSE 

into the United States, and the person 

importing the tallow has obtained a 

United States Veterinary Permit for 

Importation and Transportation of 

Controlled Materials and Organisms and 

Vectors. To apply for a permit, file a 

permit application on VS Form 16–3 

(available from APHIS, Veterinary 

Services, National Center for Import and 

Export, 4700 River Road Unit 38, 

Riverdale, MD 20737–1231, or 

electronically at http://

www.aphis.usda.gov/animal_health/

permits/). The application for such a 

permit must state the intended use of 

the tallow and the name and address of 

the consignee in the United States. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

§ 95.9 Derivatives of tallow derived from 

bovines. 

(a) The importation of derivatives of 

tallow from bovines is prohibited unless 

the commodity meets the conditions of 

either paragraph (b), (c), (d), or (e) of 

this section as well as paragraph (f) of 

this section, or, alternatively, meets the 

conditions of paragraph (g) of this 

section. 

(b) The commodity meets the 

definition of tallow derivative in § 95.1. 

(c) The derivative is from tallow 

composed of a maximum level of 

insoluble impurities of 0.15 percent in 

weight. 

(d) The derivative is from tallow that 

originates from a region of negligible 

risk for BSE. 

(e) The derivative is from tallow that 

originates from a region of controlled 

risk for BSE, is derived from bovines 

that have passed ante-mortem and postmortem inspections, and does not 

contain SRMs as defined for regions of 

controlled risk for BSE in § 92.1 of this 

subchapter. 

(f) The tallow derivative is 

accompanied to the United States by an 

original certificate signed by a full-time 

salaried veterinary officer of the 

national government of the exporting 

region, or issued by a veterinarian 

designated by the national government 

of the exporting region and endorsed by 

a full-time salaried veterinary officer of 

the national government of the 

exporting region, representing that the 

veterinarian issuing the certificate was 

authorized to do so. The certificate must 

state that the requirements of paragraph 

(b), (c), (d), or (e) of this section, as 

applicable, have been met and, for 

tallow derivatives other than those 

described in paragraph (b) or (c) of this 

section, must indicate the BSE risk 

classification of the exporting region. 

(g) The Administrator determines that 

the tallow derivative will not come into 

contact with ruminants in the United 

States and can be imported under 

conditions that will prevent the 

introduction of BSE into the United 

States, and the person importing the 

tallow derivative has obtained a United 

States Veterinary Permit for Importation 

and Transportation of Controlled 

Materials and Organisms and Vectors. 

To apply for a permit, file a permit 

application on VS Form 16–3 (available 

from APHIS, Veterinary Services, 

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Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Rules and Regulations 73005 

National Center for Import and Export, 

4700 River Road Unit 38, Riverdale, MD 

20737–1231, or electronically at http:// 

www.aphis.usda.gov/animal_health/

permits/). The application for such a 

permit must state the intended use of 

the tallow derivative and the name and 

address of the consignee in the United 

States. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

§ 95.10 Dicalcium phosphate derived from 

bovines. 

(a) The importation of dicalcium 

phosphate derived from bovines is 

prohibited unless: 

(1) The requirements of either 

paragraph (b), (c), or (d) and the 

requirements of paragraph (e) of this 

section are met; or 

(2) The requirements of paragraph (f) 

of this section are met. 

(b) The dicalcium phosphate contains 

no trace of protein or fat; or 

(c) The dicalcium phosphate 

originates from a region of negligible 

risk for BSE; or 

(d) The dicalcium phosphate 

originates from a region of controlled 

risk for BSE, is derived from bovines 

that have passed ante-mortem and postmortem inspections, and does not 

contain SRMs as defined for regions of 

controlled risk for BSE in § 92.1 of this 

subchapter. 

(e) The dicalcium phosphate is 

accompanied by an original certificate 

signed by a full-time salaried veterinary 

officer of the national government of the 

exporting region, or issued by a 

veterinarian designated by the national 

government of the exporting region and 

endorsed by a full-time salaried 

veterinary officer of the national 

government of the exporting region, 

representing that the veterinarian 

issuing the certificate was authorized to 

do so. The certificate must indicate the 

BSE risk classification of the exporting 

region and state that the requirements of 

paragraph (b) (c), or (d) of this section, 

as applicable, have been met. 

(f) The Administrator determines that 

the dicalcium phosphate will not come 

into contact with ruminants in the 

United States and can be imported 

under conditions that will prevent the 

introduction of BSE into the United 

States, and the person importing the 

dicalcium phosphate has obtained a 

United States Veterinary Permit for 

Importation and Transportation of 

Controlled Materials and Organisms and 

Vectors. To apply for a permit, file a 

permit application on VS Form 16–3 

(available from APHIS, Veterinary 

Services, National Center for Import and 

Export, 4700 River Road Unit 38, 

Riverdale, MD 20737–1231, or 

electronically at http://

www.aphis.usda.gov/animal_health/

permits/). The application for such a 

permit must state the intended use of 

the dicalcium phosphate and the name 

and address of the consignee in the 

United States. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

§ 95.11 Specified risk materials. 

Notwithstanding any other provisions 

of this part, the importation of specified 

risk materials from controlled-risk 

regions or undetermined-risk regions for 

BSE, and any commodities containing 

such materials, is prohibited, unless the 

Administrator determines that the 

materials or other commodities will not 

come into contact with ruminants in the 

United States and can be imported 

under conditions that will prevent the 

introduction of BSE into the United 

States, and the person importing the 

materials or other commodities has 

obtained a United States Veterinary 

Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors. To apply 

for a permit, file a permit application on 

VS Form 16–3 (available from APHIS, 

Veterinary Services, National Center for 

Import and Export, 4700 River Road 

Unit 38, Riverdale, MD 20737–1231, or 

electronically at http://

www.aphis.usda.gov/animal_health/

permits/). The application for such a 

permit must state the intended use of 

the materials and other commodities 

and the name and address of the 

consignee in the United States. 

§ 95.12 Blood and blood products derived 

from bovines. 

The importation of bovine blood and 

products derived from bovine blood is 

prohibited unless the following 

conditions and the conditions of all 

other applicable parts of this chapter are 

met: 

(a) For blood collected at slaughter 

and for products derived from blood 

collected at slaughter: 

(1) The blood was collected in a 

hygienic manner, as determined by the 

Administrator, that prevents 

contamination of the blood with SRMs; 

and 

(2) The slaughtered animal passed 

ante-mortem inspection and was not 

subjected to a pithing process or to a 

stunning process with a device injecting 

compressed air or gas into the cranial 

cavity. 

(b) For blood collected from live 

donor bovines and for products derived 

from blood collected from live donor 

bovines: 

(1) The blood was collected in a 

hygienic manner, as determined by the 

Administrator, that prevents 

contamination of the blood with SRMs; 

and 

(2) The donor animal was free of 

clinical signs of disease. 

(c) The blood and blood products are 

accompanied to the United States by an 

original certificate that states that the 

conditions of this section have been 

met. The certificate must be issued by 

a full-time salaried veterinary officer of 

the national government of the 

exporting region, or issued by a 

veterinarian designated by the national 

government of the exporting region and 

endorsed by a full-time salaried 

veterinary officer of the exporting 

region, representing that the 

veterinarian issuing the certificate was 

authorized to do so. 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

§ 95.13 Importation from regions of 

negligible risk for BSE of processed animal 

protein derived from animals other than 

ruminants. 

The importation from regions of 

negligible risk for BSE of processed 

animal protein derived from animals 

other than ruminants is prohibited 

importation into the United States 

unless the following conditions are met: 

(a) The processed animal protein is 

not prohibited importation under § 95.4; 

(b) The processed animal protein 

imported into the United States in 

accordance with this section is 

accompanied by an original certificate 

signed by a full-time salaried veterinary 

officer of the national government of the 

exporting region, or issued by a 

veterinarian designated by the national 

government of the exporting region and 

endorsed by a full-time salaried 

veterinary officer of the national 

government of the exporting region, 

representing that the veterinarian 

issuing the certificate was authorized to 

do so, that indicates that the material is 

derived from animals other than 

ruminants. 

(c) The person importing the 

shipment has applied for and obtained 

from APHIS a United States Veterinary 

Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors. To apply 

for a permit, file a permit application on 

VS Form 16–3 (available from APHIS, 

Veterinary Services, National Center for 

Import and Export, 4700 River Road 

Unit 38, Riverdale, MD 20737–1231, or 

electronically at http://

www.aphis.usda.gov/animal_health/

permits/). 

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(Approved by the Office of Management and 

Budget under control number 0579–0393) 

§ 95.14 Importation from regions of 

controlled risk or undetermined risk for 

BSE of processed animal protein derived 

from animals other than ruminants. 

The importation from regions of 

controlled risk or undetermined risk for 

BSE of processed animal protein 

derived from animals other than 

ruminants is prohibited importation 

into the United States unless the 

following conditions are met: 

(a) The processed animal protein is 

not prohibited importation under § 95.4; 

(b) Except as provided in paragraph 

(c) of this section, the processed animal 

protein does not contain and was not 

commingled with material derived from 

ruminants originating in a BSE 

controlled- or undetermined-risk region; 

(c) For blood meal, blood plasma, and 

other blood products, the material does 

not contain and was not commingled 

with ruminant blood or blood products 

prohibited importation into the United 

States under this part. 

(d) Inspection of the facility for 

compliance with the provisions of this 

section is conducted at least annually by 

a competent authority of the 

government agency responsible for 

animal health in the region, unless the 

region chooses to have such inspections 

conducted by APHIS. The inspections 

must verify either that: 

(1) All steps of processing and storing 

the material are carried out in a facility 

that has not been used for the 

processing or storage of materials 

derived from ruminants originating in a 

BSE controlled- or undetermined-risk 

region; or 

(2) The material is produced in a 

manner that prevents contamination of 

the processed animal protein with 

materials prohibited importation into 

the United States. 

(e) If APHIS conducts the inspections 

required by paragraph (d) of this 

section, the facility has entered into a 

cooperative service agreement executed 

by the operator of the facility and 

APHIS. In accordance with the 

cooperative service agreement, the 

facility must be current in paying all 

costs for a veterinarian of APHIS to 

inspect the facility (it is anticipated that 

such inspections will occur 

approximately once per year), including 

travel, salary, subsistence, 

administrative overhead, and other 

incidental expenses (including excess 

baggage provisions up to 150 pounds). 

In addition, the facility must have on 

deposit with APHIS an unobligated 

amount equal to the cost for APHIS 

personnel to conduct one inspection. As 

funds from that amount are obligated, a 

bill for costs incurred based on official 

accounting records will be issued to 

restore the deposit to the original level, 

revised as necessary to allow for 

inflation or other changes in estimated 

costs. To be current, bills must be paid 

within 14 days of receipt. 

(f) The facility allows periodic APHIS 

inspection of its facilities, records, and 

operations. 

(g) The processed animal protein 

imported into the United States in 

accordance with this section is 

accompanied by an original certificate 

signed by a full-time, salaried veterinary 

officer of the national government of the 

exporting region, or issued by a 

veterinarian designated by the national 

government of the exporting region and 

endorsed by a full-time, salaried 

veterinary officer of the national 

government of the exporting region, 

representing that the veterinarian 

issuing the certificate was authorized to 

do so, that states that the processed 

animal protein is not of ruminant origin 

and that conditions of this section have 

been met. 

(h) The person importing the 

shipment has applied for and obtained 

from APHIS a United States Veterinary 

Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors. To apply 

for a permit, file a permit application on 

VS Form 16–3 (available from APHIS, 

Veterinary Services, National Center for 

Import and Export, 4700 River Road 

Unit 38, Riverdale, MD 20737–1231, or 

electronically at http://

www.aphis.usda.gov/animal_health/

permits/). 

(Approved by the Office of Management and 

Budget under control number 0579–0393) 

§ 95.15 Transit shipment of articles. 

Articles that are otherwise prohibited 

importation into the United States in 

accordance with §§ 95.4 through 95.14 

may transit air and ocean ports in the 

United States for immediate export if 

the conditions of paragraphs (a) through 

(c) of this section are met. Articles are 

eligible to transit the United States by 

overland transportation if the 

requirements of paragraphs (a) through 

(e) of this section are met. 

(a) The articles must be sealed in 

leakproof containers bearing serial 

numbers during transit. Each container 

must remain sealed during the entire 

time that it is in the United States. 

(b) Before such transit, the person 

moving the articles must notify, in 

writing, the inspector at both the place 

in the United States where the articles 

will arrive and the port of export. The 

notification must include the: 

(1) Times and dates of arrival in the 

United States; 

(2) Times and dates of exportation 

from the United States; and 

(3) Serial numbers of the sealed 

containers. 

(c) The articles must transit the 

United States under Customs bond. 

(d) The person moving the articles 

must obtain a United States Veterinary 

Permit for Importation and 

Transportation of Controlled Materials 

and Organisms and Vectors. To apply 

for a permit, file a permit application on 

VS Form 16–3 (available from APHIS, 

Veterinary Services, National Center for 

Import and Export, 4700 River Road 

Unit 38, Riverdale, MD 20737–1231, or 

electronically at http://

www.aphis.usda.gov/animal_health/

permits/). 

(e) The commodities must be eligible 

to enter the United States in accordance 

with §§ 95.4 through 95.14 and must be 

accompanied by the certification 

required by that section. Additionally, 

the following conditions must be met: 

(1) The shipment must be exported 

from the United States within 7 days of 

its entry; 

(2) The commodities may not be 

transloaded while in the United States, 

except for direct transloading under the 

supervision of an authorized inspector, 

who must break the seals of the national 

government of the exporting region on 

the means of conveyance that carried 

the commodities into the United States 

and seal the means of conveyance that 

will carry the commodities out of the 

United States with seals of the U.S. 

Government; and 

(3) A copy of the import permit 

required under paragraph (d) of this 

section must be presented to the 

inspector at the port of arrival and the 

port of export in the United States. 

§ 95.16 [Amended] 

■ 33. In newly redesignated § 95.16, 

footnote 1 is amended by removing the 

citation ‘‘§ 95.30’’ and adding ‘‘§ 95.41’’ 

in its place. 

§ 95.17 [Amended] 

■ 34. In newly redesignated § 95.17, the 

introductory text is amended by 

removing the citation ‘‘§ 95.5’’ and 

adding the citation ‘‘§ 95.16’’ in its 

place. 

§ 95.18 [Amended] 

■ 35. In newly redesignated § 95.18, the 

introductory text is amended by 

removing the citation ‘‘§ 95.8’’ and 

adding the citation ‘‘§ 95.19’’ in its 

place, and footnote 3 to paragraph (c) is 

amended by removing the citation 

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‘‘§ 95.5’’ and adding the citation 

‘‘§ 95.16’’ in its place. 

§ 95.19 [Amended] 

■ 36. In newly redesignated § 95.19, the 

introductory text is amended by 

removing the citation ‘‘§ 95.7’’ and 

adding the citation ‘‘§ 95.18’’ in its 

place. 

§ 95.20 [Amended] 

■ 37. In newly redesignated § 95.20, the 

introductory text is amended by 

removing the citation ‘‘§ 95.10’’ and 

adding the citation ‘‘§ 95.21’’ in its 

place, and footnote 4 to paragraph (c) is 

amended by removing the citation 

‘‘§ 95.5’’ and adding the citation 

‘‘§ 95.16’’ in its place. 

§ 95.21 [Amended] 

■ 38. In newly redesignated § 95.21, the 

introductory text is amended by 

removing the citation ‘‘§ 95.9’’ and 

adding the citation ‘‘§ 95.20’’ in its 

place. 

§ 95.23 [Amended] 

■ 39. In newly redesignated § 95.23, the 

introductory text is amended by 

removing the citation to ‘‘§ 95.11’’ and 

adding the citation ‘‘§ 95.22’’ in its 

place. 

§ 95.25 [Amended] 

■ 40. In newly redesignated § 95.25, the 

introductory text is amended by 

removing the citation ‘‘§ 95.16’’ and 

adding the citation ‘‘§ 95.27’’ in its 

place. 

§ 95.26 [Amended] 

■ 41. Newly redesignated § 95.26 is 

amended by removing the citation 

‘‘§ 95.16’’ and adding the citation 

‘‘§ 95.27’’ in its place. 

§ 95.27 [Amended] 

■ 42. In newly redesignated § 95.27, the 

introductory text is amended by 

removing the citation ‘‘§ 95.15’’ and 

adding the citation ‘‘§ 95.26’’ in its 

place. 

§ 95.28 [Amended] 

■ 43. In newly redesignated § 95.28, the 

introductory text is amended by 

removing the citation ‘‘§ 95.18’’ and 

adding the citation ‘‘§ 95.29’’ in its 

place. 

§ 95.29 [Amended] 

■ 44. Newly redesignated § 95.29 is 

amended by removing the citation 

‘‘§ 95.17’’ and adding the citation 

‘‘§ 95.28’’ in its place. 

§ 95.32 [Amended] 

■ 45. Newly redesignated § 95.32 is 

amended by removing the citation 

‘‘§ 95.28’’ and adding the citation 

‘‘§ 95.39’’ in its place, and by removing 

the citation ‘‘§ 95.22’’ and adding the 

citation ‘‘§ 95.33’’ in its place. 

§ 95.33 [Amended] 

■ 46. Newly redesignated § 95.33 is 

amended by removing the citation 

‘‘§ 95.28’’ and adding the citation 

‘‘§ 95.39’’ in its place, and by removing 

the citation ‘‘§ 95.21’’ and adding the 

citation ‘‘§ 95.32’’ in its place. 

§ 95.36 [Amended] 

■ 47. In newly redesignated § 95.36, 

paragraphs (a) and (b) are amended by 

removing the citation ‘‘§ 95.26’’ both 

times it appears and adding the citation 

‘‘§ 95.37’’ in their place. 

■ 48. Newly redesignated § 95.40 is 

revised to read as follows: 

§ 95.40 Certification for certain materials. 

(a) In addition to meeting any other 

certification or permit requirements of 

this chapter, the following articles, if 

derived from ovines or caprines, may be 

imported into the United States from 

any region not listed in § 95.4(a)(4) only 

if they are accompanied by a certificate, 

as described in paragraph (b) of this 

section: 

(1) Processed animal protein, tankage, 

offal, and tallow other than tallow 

derivatives, unless, in the opinion of the 

Administrator, the tallow cannot be 

used in feed; 

(2) Glands and unprocessed fat tissue; 

(3) Processed fats and oils, and 

derivatives of processed animal protein, 

tankage, and offal; 

(4) Derivatives of glands; and 

(5) Any product containing any of the 

materials listed in paragraphs (a)(1) 

through (a)(4) of this section. 

(b) The certificate required by 

paragraph (a) of this section must be an 

original official certificate, signed by a 

full-time, salaried veterinarian of the 

agency responsible for animal health in 

the exporting region, that states the 

following: 

(1) The animal species from which the 

material was derived; 

(2) The region in which any facility 

where the material was processed is 

located; 

(3) That the material was derived only 

from animals that have never been in 

any region listed in § 95.4(a)(4), with the 

regions listed in § 95.4(a)(4) specifically 

named; 

(4) That the material did not originate 

in, and was never stored, rendered, or 

processed in, or otherwise associated 

with, a facility in a region listed in 

§ 95.4(a)(4); and 

(5) The material was never associated 

with any of the materials listed in 

paragraph (a) of this section that have 

been in a region listed in § 95.4(a)(4). 

(c) The certification required by 

paragraph (a) of this section must 

clearly correspond to the shipment by 

means of an invoice number, shipping 

marks, lot number, or other method of 

identification. 

(Approved by the Office of Management and 

Budget under control number 0579–0234) 

PART 96—RESTRICTION OF 

IMPORTATIONS OF FOREIGN ANIMAL 

CASINGS OFFERED FOR ENTRY INTO 

THE UNITED STATES 

■ 49. The authority citation for part 96 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 21 U.S.C. 

136 and 136a; 7 CFR 2.22, 2.80, and 371.4. 

■ 50. In § 96.2, paragraph (b) is revised 

and paragraph (c) is added to read as 

follows: 

§ 96.2 Prohibition of casings due to 

African swine fever and bovine spongiform 

encephalopathy. 

* * * * * 

(b) Casings from ovines or caprines. 

The importation of casings, except 

stomachs, derived from ovines or 

caprines that originated in or were 

processed in any region listed in 

§ 95.4(a)(4) are prohibited, unless the 

following conditions are met: 

(1) The casings are derived from 

sheep that were slaughtered in Canada 

at less than 12 months of age and that 

were from a flock subject to a ruminant 

feed ban equivalent to the requirements 

established by the U.S. Food and Drug 

Administration at 21 CFR 589.2000; and 

(2) The casings are accompanied by 

an original certificate that meets the 

requirements of § 96.3 and: 

(i) States that the casings meet the 

conditions of this section; 

(ii) Is written in English; 

(iii) Is signed by an individual eligible 

to issue the certificate required under 

§ 96.3; and 

(iv) Is presented to an authorized 

inspector at the port of entry. 

(c) Casings from bovines. The 

importation of casings derived from 

bovines is prohibited, unless the 

following conditions are met: 

(1) If the casings are derived from 

bovines from a region of negligible risk 

for BSE, as defined in § 92.1 of this 

subchapter, the certificate required 

under § 96.3 indicates the APHIS BSE 

risk classification of the region in which 

the bovines were slaughtered and the 

casings were collected. 

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(2) If the casings are derived from 

bovines from a region of controlled risk 

for BSE or a region of undetermined risk 

for BSE, as defined in § 92.1 of this 

subchapter, the casings are not derived 

from the small intestine or, if the 

casings are derived from the small 

intestine, the casings are derived from 

that part of the small intestine that is 

eligible for use as human food in 

accordance with the requirements 

established by the Food Safety and 

Inspection Service at 9 CFR 310.22 and 

the Food and Drug Administration at 21 

CFR 189.5. 

(3) The casings are accompanied by 

an original certificate that meets the 

requirements of § 96.3 and paragraphs 

(b)(2)(i) through (b)(3)(iv) of this section. 

* * * * * 

■ 51. In § 96.3, paragraph (d) is revised 

to read as follows: 

§ 96.3 Certificate for animal casings. 

* * * * * 

(d) In addition to meeting the 

requirements of this section, the 

certificate accompanying sheep casings 

from Canada must state that the casings 

meet the requirements of § 96.2(b) and 

the certificate accompanying bovine 

casings must state that the casings meet 

the requirements of either § 96.2(c)(1) or 

(c)(2) as applicable. 

* * * * * 

PART 98—IMPORTATION OF CERTAIN 

ANIMAL EMBRYOS AND ANIMAL 

SEMEN 

■ 52. The authority citation for part 98 

continues to read as follows: 

Authority: 7 U.S.C. 1622 and 8301–8317; 

21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 

CFR 2.22, 2.80, and 371.4. 

■ 53. Section 98.11 is amended by 

adding definitions of camelid and 

cervid, in alphabetical order, to read as 

follows: 

§ 98.11 Definitions. 

* * * * * 

Camelid. All species of the family 

Camelidae, including camels, guanacos, 

llamas, alpacas, and vicunas. 

Cervid. All members of the family 

Cervidae and hybrids, including deer, 

elk, moose, caribou, reindeer, and 

related species. 

* * * * * 

■ 54. In § 98.15, the introductory text of 

paragraph (a) is revised to read as 

follows: 

§ 98.15 Health requirements. 

* * * * * 

(a) The donor dam is determined to be 

free of communicable diseases based on 

tests, examinations, and other 

requirements, as follows, except that, 

with regard to bovine spongiform 

encephalopathy, the following does not 

apply to bovines, cervids, or camelids. 

* * * * * 

Done in Washington, DC, this 19th day of 

November 2013. 

Max T. Holtzman, 

Acting Deputy Under Secretary for Marketing 

and Regulatory Programs. 

[FR Doc. 2013–28228 Filed 12–3–13; 8:45 am] 

BILLING CODE 3410–34–P 

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